Reported May 23, 2018 · Terminated

PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and…

Invivo Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Invivo Corporation · 12151 Research Pkwy Ste 200 · Orlando, FL · 32826-3286

Is this the product you have?

PHILIPS Xper Flex Cardio Physiomonitoring System
Model Numbers453564241901, 453564483321, 453564621791, and 989803199561 (international only) The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers

Lot codes and dates: Model Number453564241901
Serial Numbers/UDI (if available)
US1203010330
US1203010371
US1203010373
US1203010382
US1203010400
US1203010413
US1203010421
US1311000007
US1311000009/
(01)00884838083523(21)US1239000009 US1311000017/ (01)00884838083523(21)US1331000034
US1239000009
US1331000034
US1231000061
US1108010053
US1202010217
US1234000060
US1337000038
US1337000040
US1337000043
US1343000024
US1334000021
US1234000066
US1202010242/
(01)00884838083523(21)US1202010242 US1244000002/ (01)00884838083523(21)US1244000002 US1251000087/ (01)00884838083523(21)US1251000087 US1202010168 US1203010284 US1244000061 US1251000005 US1203010302/ (01)00884838083523(21)US1203010302 US1244000016/ (01)00884838083523(21)US1203010340 US1231000038/ (01)00884838083523(21)US1231000038 US1234000024/ (01)00884838083523(21)US1234000024 US1244000016/ (01)00884838083523(21)US1244000016 US1244000040/ (01)00884838083523(21)US1244000040 US1244000066/ (01)00884838083523(21)US1244000066 US1251000013/ (01)00884838083523(21)US1251000013 US1311000025/ (01)00884838083523(21)US1311000025 US1319000059/ (01)00884838083523(21)US1319000059 US1337000032/ (01)00884838083523(21)US1337000032 US1231000048/ (01)00884838084926(21)US1231000048 US1251000031/ (01)00884838084926(21)US1251000031 US1304000040/ (01)00884838084926(21)US1304000040 US1334000041/ (01)00884838084926(21)US1334000041
64 of 64 codes
US1107010016
US1107010019
US1107010022
US1107010036
US1108010062
US1109010104
US1202010153
US1202010173
US1202010233
US1203010261
US1203010295
US1203010307
US1203010320
US1203010345
US1203010377
US1231000022
US1234000013
US1234000049
US1239000024
US1239000045
US1244000032
US1244000055
US1248000023
US1251000030
US1251000033
US1251000052
US1251000077
US1304000020
US1311000069
US1319000009
US1319000016
US1319000030
US1319000069
US1324000008
US1324000014
US1324000039
US1328000002
US1331000040
US1337000055
US1343000001
US1343000009
US1343000027
US1343000059
US1343000073
US1239000002
US1352000047
US1324000011
US1319000038
US1239000019
US1107010007
US1201010117
US1201010119
US1203010401
US1231000026
US1231000049
US1231000059
US1234000051
US1325000009
US1234000086
US1238000005
(01)00884838083523(21)US1248000041 US1239000011 US1202010208/ 01)00884838083523(21)US1202010208 US1244000054/ (01)00884838083523(21)US1244000054 US1324000049/ (01)00884838083523(21)US1324000049
US1234000068
US1239000008
US1319000091
US1325000017
US1107010011
US1231000058
US1337000024
US1325000007/
(01)00884838083523(21)US1325000007
US1328000014
US1331000067
US1201010129
US1224000051
US1231000008
US1231000016
US1231000028
US1319000024
US1337000071
US1251000053
US1231000046
US1311000002/
(01)00884838083523(21)US1311000002 US1311000054/ (01)00884838083523(21)US1311000054
US1109010076
US1201010113
US1201010116
US1201010144
US1202010189
US1337000028
US1352000020
US1319000097
US1325000002
US1311000029/
(01)00884838083530(21)US1311000029 US1107010020 US1108010040 US1231000036 US1107010008 US1251000010 US1331000038/ (01)00884838083523(21)US1331000038 US1244000022/ (01)00884838083523(21)US1244000022 US1311000058/ (01)00884838083523(21)US1311000058 US1331000057/ (01)00884838083530(21)US1331000057
US1107010037
US1244000019
US1324000032
US1331000028
US1334000032
US1319000047
US1324000029
US1325000020
US1248000019
US1234000048
US1244000042
US1244000053
US1248000032
US1203010291
US1337000019
US1319000033/
(01)00884838083523(21)US1319000033 US1244000036/ (01)00884838084926(21)US1244000036
US1109010092
US1201010143
US1203010386
US1352000003
US1352000012
US1407000022
US1319000060
US1251000050
US1319000001
US1224000044
US1109010098
US1107010015
US1107010023
US1108010041
US1109010068
US1407000002
US1407000029
US1407000031
US1304000027
US1231000067
US1231000073
US1304000034
US1324000030/
(01)00884838083523(21)US1324000030
US1224000012
US1337000050
US1337000066
US1202010149
US1202010176
US1203010348
US1231000034
US1109010081
US1203010265
US1239000006
US1234000021
US1319000015
US1203010316
US1231000010
US1201010132
US1107010012
US1107010017
US1107010021
US1108010059
US1201010115
US1234000083
US1319000052
US1337000018
US1337000048
US1304000011
US1319000029
US1331000004
US1251000038/
(01)00884838083523(21)US1251000038
US1202010196
US1202010197
US1203010354
US1248000008
US1408000013
US1203010357
US1248000018
US1328000012
US1331000033
US1224000002
US1319000094
US1331000016
US1343000056
US1343000020
US1109010107/
(01)00884838083523(21)US1109010107
US1324000018
US1343000060
US1201010138
US1251000073
US1201010123
US1203010351
US1109010086
US1248000056
US1304000002
US1331000052
US1343000012
US1231000042
US1107010027
US1203010391
US1231000062
US1239000026
US1311000018
US1311000026
US1311000044
US1248000017
US1248000066
US1319000020
US1331000064
US1244000018
US1325000022/
(01)00884838083523(21)US1325000022 US1324000022/ (01)00884838084926(21)US1324000022
US1244000067
US1248000006
US1248000013
US1248000020
US1248000049
US1248000051
US1248000062
US1319000005
US1202010200
US1202010177
US1202010191
US1324000033
US1234000087/
(01)00884838083523(21)US1234000087 US1203010264/ (01)00884838083530(21)US1203010264
US1203010376
US1203010388
US1231000047
US1304000026
US1244000046
US1319000026
US1203010389
US1244000060
US1248000060
US1337000020
US1343000065
US1407000054
US1331000018
US1109010066
US1109010077
US1109010111
US1109010088
US1107010001
US1203010266
US1203010321
US1203010390
US1319000098
US1234000072/
(01)00884838083523(21)US1234000072 US1311000021/ (01)00884838083523(21)US1311000021
US1202010205
US1202010210
US1203010329
US1239000025
US1319000004
US1319000084
US1352000009
US1352000063
US1407000055
US1203010288/
(01)00884838083523(21)US1203010288 US1244000028/ (01)00884838083523(21)US1244000028
US1324000012
US1239000015
US1224000025
US1324000006
US1324000051
US1343000050
US1231000030
US1251000047
US1331000017
US1337000030
US1337000036
US1337000051
US1337000054
US1337000062
US1337000063
US1337000064
US1109010094
US1224000053
US1231000044
US1248000055
US1319000054
US1325000016
US1328000005
US1224000043
US1231000086
US1311000005
US1324000013
US1337000059
US1343000071
US1343000077
US1343000091
US1239000050
US1224000001
US1248000054
US1304000013
US1248000043
US1202010201
US1251000017/
(01)00884838083523(21)US1251000017
US1109010103
US1239000032
US1319000011
US1319000027
US1334000002
US1334000027
US1319000086
US1202010203
US1231000040
US1331000009
US1203010253
US1203010258
US1203010303
US1203010344
US1203010368
US1108010050
US1108010063
US1311000030
US1311000008/
(01)00884838083523(21)US1311000008
US1107010024
US1234000059
US1343000066
US1202010241
US1210000005
US1224000011
US1224000019
US1224000054
US1407000006
US1407000047
US1407000050
US1407000051
US1408000005
US1408000021
US1408000022
US1408000027
US1408000028
US1408000030
US1203010412
US1319000032
US1311000034/
(01)00884838083523(21)US1311000034 US1224000040/ (01)00884838083523(21)US1224000040
US1231000003
US1231000005
US1231000006
US1234000028
US1231000053
US1202010158
US1202010159
US1202010162
US1202010163
US1331000054/
(01)00884838084926(21)US1331000054 US1337000014/ (01)00884838084926(21)US1337000014 US1324000028 US1248000047 US1251000029 US1407000039 US1319000055 US1234000030 US1109010071/ (01)00884838083523(21)US1109010071 US1203010272/ (01)00884838083523(21)US1203010272 US1203010296/ (01)00884838083523(21)US1203010296 US1203010394/ (01)00884838083523(21)US1203010394 US1224000008/ (01)00884838083523(21)US1224000008 US1224000026/ (01)00884838083523(21)US1224000026 US1231000009/ (01)00884838083523(21)US1231000009 US1234000002/ (01)00884838083523(21)US1234000002 US1234000007/ (01)00884838083523(21)US1234000007 US1234000082/ (01)00884838083523(21)US1234000082 US1244000052/ (01)00884838083523(21)US1244000052 US1311000051/ (01)00884838083523(21)US1311000051 US1311000071/ (01)00884838083523(21)US1311000071 US1325000024/ (01)00884838083523(21)US1325000024 US1337000006/ (01)00884838083523(21)US1337000006 US1337000073/ (01)00884838083523(21)US1337000073 US1231000015/ (01)00884838083530(21)US1231000015
US1108010046
US1109010096
US1201010131
US1202010170
US1202010188
US1203010252
US1203010300
US1203010331
US1203010370
US1203010403
US1203010405
US1224000022
US1231000024
US1231000079
US1234000043
US1234000052
US1234000063
US1234000073
US1234000090
US1239000001
US1239000010
US1239000037
US1239000041
US1239000043
US1244000015
US1244000020
US1244000037
US1248000022
US1248000033
US1248000040
US1248000061
US1251000007
US1251000035
US1304000033
US1304000044
US1311000020
US1311000022
US1311000032
US1311000053
US1319000021
US1319000040
US1319000063
US1319000089
US1325000008
US1325000015
US1328000001
US1343000069
US1244000035/
(01)00884838083523(21)US1244000035 US1319000013/ (01)00884838083523(21)US1319000013 US1231000070 US1202010167 US1202010182 US1202010193 US1343000004 US1202010225/ (01)00884838083523(21)US1202010225 US1319000023 US1325000004 US1311000067 US1248000048/ (01)00884838083523(21)US1248000048
US1202010183
US1248000053
US1251000037
US1334000024
US1337000060
US1324000026-D
US1202010207
US1244000049
US1201010114
US1201010118
US1319000057
US1201010125
US1203010380
US1251000028
US1324000007
US1248000027
US1203010410
US1244000001
US1244000057
US1319000041
US1337000065
US1352000029
US1352000053
US1352000058
US1311000057
US1234000089/
(01)00884838084926(21)US1234000089
US1203010356
US1201010127
US1202010211
US1203010286
US1203010310
US1203010335
US1244000004
US1244000012
US1311000039
US1331000037
US1224000015/
(01)00884838083523(21)US1224000015 US1109010067 US1109010110/ (01)00884838083523(21)US1109010110 US1248000045/ (01)00884838083523(21)US1248000045 US1325000019 US1202010157/ (01)00884838083523(21)US1202010157 US1319000045/ (01)00884838083523(21)US1319000045
US1231000055
US1239000035
US1311000024
US1319000007
US1324000003
US1324000020
US1201010121
US1203010324
US1224000038
US1234000071
US1248000016
US1203010267
US1244000064
US1311000010
US1319000066
US1251000054/
(01)00884838083523(21)US1251000054
US1352000002
US1108010055
US1201010133
US1201010137
US1202010186
US1203010290
US1203010337
US1337000009
US1324000034
US1324000038/
(01)00884838083523(21)US1324000038 US1203010385 US1224000009 US1231000014 US1234000078 US1324000010 US1324000036 US1324000035/ (01)00884838083523(21)US1324000035
US1202010238
US1248000064
US1311000056
US1412000008
US1234000041
US1107010025
US1107010077
US1334000007
US1352000011
US1352000027
US1203010417/
(01)00884838083523(21)US1203010417 US1203010404 US1352000050 US1202010209/ (01)00884838083523(21)US1202010209 US1337000049/ (01)00884838083523(21)US1337000049
US1248000078
US1251000002
US1251000078
US1319000003
US1319000028
US1325000026
US1331000061
US1107010033
US1251000055
US1337000011
US1203010342
US1108010049/
(01)00884838083523(21)US1108010049 US1234000046/ (01)00884838083523(21)US1234000046 US1319000006/ (01)00884838083523(21)US1319000006
US1319000035
US1343000058
US1311000050
US1238000009
US1331000010
US1234000039
US1234000047
US1234000061
US1239000016
US1108010042
US1202010160
US1202010214
US1231000025
US1248000009
US1203010281
US1203010313
US1203010350
US1203010355
US1324000043/
(01)00884838083523(21)US1324000043 US1352000055 US1202010213 US1202010226 US1202010231 US1234000011 US1304000025 US1231000037/ (01)00884838083523(21)US1231000037 US1203010392/ (01)00884838083523(21)US1203010392 US1244000021/ (01)00884838083523(21)US1244000021 US1201010112 US1231000051 US1337000052 US1319000010/ (01)00884838083523(21)US1319000010
US1203010381
US1231000027
US1337000015
US1244000008
US1334000017
US1244000007
US1325000010
US1331000015
US1331000030
US1334000033
US1334000035
US1334000036
US1334000040
US1334000042
US1334000044
US1337000026
US1231000020
US1248000074
US1231000002
US1324000015
US1202010219
US1202010224
US1202010227
US1202010236
US1202010239
US1202010248
US1203010270
US1224000007
US1202010199
US1304000047
US1311000004
US1328000006
US1202010194
US1203010347
US1238000004
US1319000079
US1331000019
US1331000024
US1331000031
US1331000046
US1331000065
US1234000031
US1251000067
US1107010030
US1319000078
US1109010097
US1224000032
US1239000007
US1331000029
US1234000042
US1311000006/
(01)00884838084926(21)US1311000006 US1319000051/ (01)00884838083523(21)US1319000051 US1311000077/ (01)00884838083523(21)US1311000077
US1328000004
US1251000021
US1324000017
US1343000070
US1234000045
US1324000025
US1203010418
US1334000026
US1334000028
US1203010414
US1319000061
US1331000014
US1108010051
US1108010061
US1337000034/
(01)00884838083523(21)US1337000034
US1109010105
US1203010289
US1203010326
US1319000064
US1324000021
US1311000080
US1231000063
US1109010083/
(01)00884838083523(21)US1109010083 US1107010010/ (01)00884838083523(21)US1107010010 US1244000005 US1109010065 US1248000036 US1109010084 US1202010175/ (01)00884838083523(21)US1202010175 US1201010122 US1248000079 US1325000025 US1201010126/ (01)00884838083523(21)US1201010126 US1234000025 US1343000013/ (01)00884838083523(21)US1343000013 US1244000065 US1334000030/ (01)00884838083523(21)US1334000030 US1108010058/ (01)00884838083523(21)US1108010058 US1201010120 US1202010166 US1251000044 US1324000026 US1304000007 US1234000056/ (01)00884838083523(21)US1234000056 US1331000060 US1311000013 US1202010155/ (01)00884838083523(21)US1202010155 US1251000020/ (01)00884838083523(21)US1251000020 US1337000003/ (01)00884838083523(21)US1337000003 US1337000022/ (01)00884838083523(21)US1337000022 US1337000042 US1343000078 US1337000012 US1203010285 US1224000033 US1234000069/ (01)00884838083523(21)US1234000069 US1343000021/ (01)00884838083523(21)US1343000021 US1304000005/ (01)00884838083523(21)US1304000005 US1231000029 US123100080 US1234000005 US1319000008 US1319000083 US1337000021 US1319000042/ (01)00884838083523(21)US1319000042
226 of 226 codes
US1325000023
US1239000048
US1319000072
US1234000079
US1251000051
US1251000097
US1319000012
US1203010411
US1203010250
US1203010256
US1203010259
US1203010263
US1203010269
US1203010273
US1203010274
US1203010275
US1203010277
US1203010282
US1203010299
US1203010301
US1203010304
US1203010312
US1203010318
US1203010365
US1203010369
US1203010372
US1203010399
US1203010406
US1203010415
US1203010416
US1203010419
US1203010424
US1210000003
US1210000004
US1224000005
US1224000028
US1224000031
US1231000001
US1231000011
US1231000021
US1231000039
US1231000041
US1231000043
US1231000054
US1231000056
US1231000072
US1231000087
US1231000088
US1231000089
US1234000010
US1234000015
US1234000022
US1234000026
US1234000027
US1234000029
US1234000033
US1234000034
US1234000038
US1234000044
US1234000065
(01)00884838083530(21)US1244000013 US1224000029 US1109010064 US1331000041/ (01)00884838083523(21)US1331000041
US1202010229
US1202010171
US1109010099
US1201010135
US1239000022
US1107010002
US1319000067
US1203010338
US1248000083
US1331000059/
(01)00884838083523(21)US1331000059 US1244000033/ (01)00884838083523(21)US1244000033 US1244000011 US1337000070/ (01)00884838083523(21)US1337000070
US1203010359
US1319000080
US1319000065
US1304000012
US1234000053
US1234000040
US1337000074
US1203010402
US1251000018
US1202010247
US1319000017
US1248000011/
(01)00884838083523(21)US1248000011 US1224000045 US1311000072 US1248000005 US1107010006/ (01)00884838083523(21)US1107010006 US1244000038 US1203010278/ (01)00884838083530(21)US1203010278 US1311000014 US1311000049 US1319000031/ (01)00884838083523(21)US1319000031 US1319000036 US1251000040
US1202010156 US1251000027 Model Number453564483321
Serial Numbers/UDI (if available)US1518000781/ (01)00884838083523(21)US1518000781 US1550001457/ (01)00884838083523(21)US1550001457 US1550001457/ (01)00884838083523(21)US1550001483 US1407000013 US1611001885 US1611001923 US1613001945 US1613001952 US1529001016/ (01)00884838083523(21)US1529001016 US1352000030/ (01)00884838083523(21)US1352000030 US1417000027 US1408000006/ (01)00884838083523(21)US1408000006 US1502000443/ (01)00884838083523(21)US1502000443 US1505000555/ (01)00884838083523(21)US1505000555 US1603001565/ (01)00884838083523(21)US1603001565 US1608001633/ (01)00884838083523(21)US1608001633
71 of 71 codes
US1107010032
US1109010106
US1202010164
US1202010243
US1231000085
US1234000032
US1234000084
US1239000004
US1239000013
US1239000018
US1239000036
US1239000042
US1239000051
US1239000052
US1244000009
US1244000017
US1244000023
US1244000029
US1244000034
US1244000043
US1248000012
US1248000044
US1248000080
US1248000082
US1251000008
US1251000024
US1251000026
US1251000057
US1251000059
US1251000065
US1251000076
US1251000079
US1251000082
US1251000088
US1304000009
US1319000077
US1319000082
US1324000016
US1324000037
US1324000041
US1324000045
US1325000006
US1325000028
US1328000009
US1328000015
US1334000011
US1334000013
US1334000020
US1334000031
US1337000001
US1337000005
US1337000013
US1337000016
US1337000017
US1337000035
US1337000039
US1337000045
US1337000084
US1343000041
US1343000054
(01)00884838082113(21)US1638002571 US1109010101/ (01)00884838083523(21)US1109010101 US1224000048/ (01)00884838083523(21)US1224000048 US1231000013/ (01)00884838083523(21)US1231000013 US1231000018/ (01)00884838083523(21)US1231000018 US1239000017/ (01)00884838083523(21)US1239000017 US1244000026/ (01)00884838083523(21)US1244000026 US1248000021/ (01)00884838083523(21)US1248000021 US1319000049/ (01)00884838083523(21)US1319000049 US1337000056/ (01)00884838083523(21)US1337000056 US1352000016/ (01)00884838083523(21)US1352000016 US1352000066/ (01)00884838083523(21)US1352000066 US1407000014/ (01)00884838083523(21)US1407000014 US1417000013/ (01)00884838083523(21)US1417000013 US1417000040/ (01)00884838083523(21)US1417000040 US1419000043/ (01)00884838083523(21)US1419000043 US1419000058/ (01)00884838083523(21)US1419000058 US1424000012/ (01)00884838083523(21)US1424000012 US1433000085/ (01)00884838083523(21)US1433000085 US1438000135/ (01)00884838083523(21)US1438000135 US1441000154/ (01)00884838083523(21)US1441000154 US1443000215/ (01)00884838083523(21)US1443000215 US1446000264/(01)00884838083523(21)US1446000264 US1446000301/ (01)00884838083523(21)US1446000301 US1450000347/ (01)00884838083523(21)US1450000347 US1505000538/ (01)00884838083523(21)US1505000538 US1505000554/ (01)00884838083523(21)US1505000554 US1511000603/ (01)00884838083523(21)US1511000603 US1517000662/ (01)00884838083523(21)US1517000662 US1518000747/ (01)00884838083523(21)US1518000747 US1518000756/ (01)00884838083523(21)US1518000756 US1525000989/ (01)00884838083523(21)US1525000989 US1529001019/ (01)00884838083523(21)US1529001019 US1529001047/ (01)00884838083523(21)US1529001047 US1529001075/ (01)00884838083523(21)US1529001075 US1529001081/ (01)00884838083523(21)US1529001081 US1533001114/ (01)00884838083523(21)US1533001114 US1534001202/ (01)00884838083523(21)US1534001202 US1534001205/ (01)00884838083523(21)US1534001205 US1534001231/ (01)00884838083523(21)US1534001231 US1537001273/ (01)00884838083523(21)US1537001273 US1537001307/ (01)00884838083523(21)US1537001307 US1547001368/ (01)00884838083523(21)US1547001368 US1547001390/ (01)00884838083523(21)US1547001390 US1547001432/ (01)00884838083523(21)US1547001432 US1550001495/ (01)00884838083523(21)US1550001495 US1603001547/ (01)00884838083523(21)US1603001547 US1604001578/ (01)00884838083523(21)US1604001578 US1608001659/ (01)00884838083523(21)US1608001659 US1609001690/ (01)00884838083523(21)US1609001690 US1609001705/ (01)00884838083523(21)US1609001705 US1611001829/ (01)00884838083523(21)US1611001829 US1611001834/ (01)00884838083523(21)US1611001834 US1611001852 /(01)00884838083523(21)US1611001852 US1617002011 /(01)00884838083523(21)US1617002011 US1623002178 /(01)00884838083523(21)US1623002178 US1623002184 /(01)00884838083523(21)US1623002184
US1343000003
US1352000034
US1352000037
US1352000061
US1407000037
US1412000044
US1417000005
US1419000028
US1424000007
US1424000013
US1431000016
US1433000052
US1438000091
US1443000211
US1443000223
US1502000465
US1505000530
US1511000580
US1511000602
US1511000608
US1511000614
US1511000643
US1517000658
US1518000764
US1518000796
US1525000923
US1529001044
US1534001153
US1537001286
US1547001404
US1547001429
US1604001592
US1609001723
US1610001764
US1610001782
US1611001855
US1623002127
US1623002134
US1625002340
US1644002650/
(01)00884838083523(21)US1644002650 US1547001385 US1511000645 US1517000655 US1408000035 US1518000789 US1638002590/ (01)00884838083523(21)US1638002590 US1638002596/ (01)00884838083523(21)US1638002596 US1547001421 US1547001426 US1547001433 US1450000345/ (01)00884838083523(21)US1450000345 US1511000574/ (01)00884838083523(21)US1511000574 US1523000873/ (01)00884838083523(21)US1523000873 US1511000599 US1203010423 US1438000120/ (01)00884838083523(21)US1438000120 US1529001057 US1623002123 US1505000496 US1623002137 US1550001447 US1550001466 US1517000668/ (01)00884838083523(21)US1517000668 US1108010054 US1417000019 US1623002115/ (01)00884838083523(21)US1623002115 US1107010038/ (01)00884838083523(21)US1107010038 US1518000786/ (01)00884838083523(21)US1518000786 US1518000801/ (01)00884838083523(21)US1518000801 US1525000912/ (01)00884838083523(21)US1525000912 US1108010056 US1412000011 US1611001893 US1604001580/ (01)00884838083523(21)US1604001580
US1417000032
US1417000038
US1443000177
US1518000784
US1529001088
US1533001103
US1537001310
US1537001314
US1446000299/
(01)00884838083523(21)US1446000299 US1511000604/ (01)00884838083523(21)US1511000604 US1625002284/ (01)00884838083523(21)US1625002284
US1412000020
US1419000006
US1419000047
US1419000056
US1419000059
US1511000635
US1518000768
US1523000839
US1547001357
US1547001420
US1419000031
US1502000380/
(01)00884838083523(21)US1502000380 US1537001288/ (01)00884838083523(21)US1537001288 US1608001646/ (01)00884838083523(21)US1608001646 US1523000885 US1547001383 US1547001438 US1550001446 US1608001650 US1608001657 US1523000848/ (01)00884838083523(21)US1523000848 US1537001258 US1547001416 US1547001439 US1625002257 US1610001801 US1611001860 US1518000785/ (01)00884838083523(21)US1518000785 US1625002237/ (01)00884838083523(21)US1625002237 US1623002154 US1203010314/ (01)00884838083523(21)US1203010314 US1412000046/ (01)00884838083523(21)US1412000046
US1443000169
US1446000295
US1505000537
US1505000545
US1511000592
US1517000650
US1517000673
US1517000687
US1517000709
US1529001049
US1529001059
US1331000026/
(01)00884838083523(21)US1331000026
US1534001181
US1624002222
US1511000633
US1525000921
US1525000939
US1523000828
US1502000472
US1517000735
US1525000904
US1547001397/
(01)00884838083523(21)US1547001397 US1619002060 US1619002061 US1619002102/ (01)00884838083523(21)US1619002102 US1446000257 US1529001032 US1625002238 US1502000453 US1638002614/ (01)00884838083523(21)US1638002614 US1638002547/ (01)00884838083530(21)US1638002547 US1638002577/ (01)00884838083530(21)US1638002577 US1517000683 US1517000699 US1537001298 US1518000765/ (01)00884838083523(21)US1518000765 US1502000434 US1518000783 US1518000795 US1638002559/ (01)00884838083523(21)US1638002559 US1525000922 US1525000961 US1443000222 US1604001623/ (01)00884838083523(21)US1604001623 US1352000056 US1523000849 US1611001902 US1505000506 US1505000510 US1505000550 US1319000025/ (01)00884838083523(21)US1319000025 US1517000719/ (01)00884838083523(21)US1517000719 US1537001318 US1523000809 US1626002421/ (01)00884838083523(21)US1626002421
US1419000001
US1419000002
US1419000019
US1529000992
US1529001051
US1604001616
US1625002266
US1502000462/
(01)00884838083523(21)US1502000462 US1438000116 US1143000182/ (01)00884838083523(21)US1143000182
US1511000626
US1511000640
US1534001235
US1534001238
US1534001240
US1534001241
US1537001261
US1547001415
US1550001449
US1617002020
US1611001868
US1613001927
US1517000737
US1625002240
US1625002242
US1626002401
US1626002407
US1623002132
US1623002158
US1623002186
US1623002193
US1624002212
US1502000454/
(01)00884838083523(21)US1502000454 US1443000197 US1638002615/ (01)00884838083523(21)US1638002615 US1644002543/ (01)00884838083523(21)US1644002543 US1644002675/ (01)00884838083523(21)US1644002675 US1611001872 US1611001908 US1625002298 US1638002537/ (01)00884838083523(21)US1638002537 US1638002548/ (01)00884838083523(21)US1638002548 US1638002550/ (01)00884838083523(21)US1638002550 US1638002610/ (01)00884838083523(21)US1638002610
US1412000049
US1623002109
US1623002152
US1624002213
US1625002227
US1625002234
US1625002241
US1625002244
US1625002263
US1550001482
US1550001488
US1609001716/
(01)00884838083523(21)US1609001716
US1424000036
US1417000034
US1419000021
US1424000002
US1438000115
US1523000867
US1604001582
US1604001590
US1331000020/
(01)00884838083523(21)US1331000020 US1407000052/ (01)00884838083523(21)US1407000052 US1502000467/ (01)00884838083523(21)US1502000467 US1523000864/ (01)00884838083523(21)US1523000864 US1529001064/ (01)00884838083523(21)US1529001064 US1431000037 US1433000049 US1433000050 US1505000536 US1608001628 US1517000689/ (01)00884838083523(21)US1517000689 US1547001398/ (01)00884838083523(21)US1547001398
US1412000036
US1517000667
US1611001871
US1625002275
US1625002277
US1604001600
US1604001614
US1613001936
US1613001960
US1644002624/
(01)00884838083523(21)US1644002624 US1644002638/ (01)00884838083523(21)US1644002638 US1623002133 US1623002163 US1623002171 US1624002216 US1624002219 US1408000025 US1324000009/ (01)00884838083523(21)US1324000009 US1419000009/ (01)00884838083523(21)US1419000009 US1446000240/ (01)00884838083523(21)US1446000240 US1511000637/ (01)00884838083523(21)US1511000637 US1517000686/ (01)00884838083523(21)US1517000686 US1523000820/ (01)00884838083523(21)US1523000820 US1529001037/ (01)00884838083523(21)US1529001037 US1529001045/ (01)00884838083523(21)US1529001045 US1529001054/ (01)00884838083523(21)US1529001054 US1529001013 US1529001072 US1550001475 US1533001102 US1610001805/ (01)00884838083523(21)US1610001805 US1352000043/ (01)00884838083523(21)US1352000043 US1424000049/ (01)00884838083523(21)US1424000049 US1443000198/ (01)00884838083523(21)US1443000198 US1511000596/ (01)00884838083523(21)US1511000596 US1523000837/ (01)00884838083523(21)US1523000837 US1608001631/ (01)00884838083523(21)US1608001631
US1352000005
US1412000037
US1417000014
US1505000559
US1604001569
US1604001608
US1352000033
US1604001603
US1604001615
US1446000254
US1446000256
US1446000266
US1502000397
US1529001087
US1529001089
US1603001541
US1547001366
US1608001658
US1547001414
US1525000990
US1529000997
US1529001055
US1502000474
US1534001210/
(01)00884838083523(21)US1534001210 US1623002143/ (01)00884838083523(21)US1623002143 US1505000525 US1517000674/ (01)00884838083523(21)US1517000674 US1534001221/ (01)00884838083523(21)US1534001221 US1608001671/ (01)00884838083523(21)US1608001671 US1424000042 US1518000802 US1547001407 US1534001179/ (01)00884838083523(21)US1534001179 US1625002232/ (01)00884838083523(21)US1625002232 US1502000446 US1517000652/ (01)00884838083523(21)US1517000652 US1611001847/ (01)00884838083523(21)US1611001847 US1638002581/ (01)00884838083523(21)US1638002581 US1619002050 US1523000888/ (01)00884838083523(21)US1523000888 US1511000624 US1518000745/ (01)00884838083523(21)US1518000745 US1244000039/ (01)00884838083523(21)US1244000039
US1343000031
US1408000050
US1550001494
US1604001583
US1609001692
US1609001696
US1609001699
US1609001691
US1626002431/
(01)00884838083523(21)US1626002431 US1626002454/ (01)00884838083523(21)US1626002454 US1352000067 US1408000026 US1533001098 US1331000043/ (01)00884838083523(21)US1331000043 US1511000605 US1533001100 US1610001753 US1433000074 US1433000087 US1523000872 US1502000471/ (01)00884838083523(21)US1502000471 US1417000037 US1511000584 US1511000618 US1433000054 US1518000780 US1109010102/ (01)00884838083523(21)US1109010102 US1502000459/ (01)00884838083523(21)US1502000459 US1609001698/ (01)00884838083523(21)US1609001698 US1625002292 US1529001067/ (01)00884838083523(21)US1529001067 US1511000591 US1525000946 US1550001464 US1550001504 US1234000050/ (01)00884838083523(21)US1234000050 US1352000051/ (01)00884838083523(21)US1352000051 US1408000048/ (01)00884838083523(21)US1408000048 US1613001926 US1613001973 US1517000660/ (01)00884838083523(21)US1517000660
US1550001477
US1611001819
US1611001846
US1611001856
US1617001996
US1617001999
US1534001194
US1534001208
US1431000024
US1438000145/
(01)00884838083523(21)US1438000145 US1610001772 US1533001116 US1533001140 US1231000080 US1638002573/ (01)00884838083523(21)US1638002573 US1109010095/ (01)00884838083523(21)US1109010095 US1239000005/ (01)00884838083523(21)US1239000005 US1408000010/ (01)00884838083523(21)US1408000010 US1517000729/ (01)00884838083523(21)US1517000729 US1537001324/ (01)00884838083523(21)US1537001324 US1547001364/ (01)00884838083523(21)US1547001364 US16230
Amount recalled: 4375 units

Where it was sold

Nationwide
PR

Why it was recalled

The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be inaccurate. Because ventricular pressure monitoring is only performed in the cardiac catheterization procedure room using the FC2010 device, the FC2020 device, which is used in the Pre or Post-Op Holding Areas, is not impacted by this issue.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Invivo Corporation recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.

By hazard

Medical device recalls

Other recalls from Invivo Corporation

18 in total.

Where it was distributed

Puerto Rico recalls

All recall categories · Browse the whole archive