Reported Apr 11, 2018 · Terminated

GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by…

GE Healthcare

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: GE Healthcare · 540 W Northwest Hwy · Barrington, IL · 60010-3051

Is this the product you have?

GE Healthcare Centricity PACS-IW
Model Numbers(a) 2052831-00X (b) 2049588-008
Product UsageCentricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations

Lot codes and dates: Model Numbers(a) 2052831-00X:
Serial Numbers
89 of 89 codes
4285-1-Centricity
PACS-IW-00558123
4479-1-Centricity
PACS-IW-00558214
4291-1-Centricity
PACS-IW-00558194
4300-1-Centricity
PACS-IW-00558207
100701-1-Centricity
PACS-IW-00558322
100979-1-Centricity
PACS-IW-00558142
4474-1-Centricity
PACS-IW-00558169
1153-1-Centricity
PACS-IW-00558162
100889-1-Centricity
PACS-IW-00558190
100891-1-Centricity
PACS-IW-00558184
100892-1-Centricity
PACS-IW-00558192
100893-1-Centricity
PACS-IW-00558171
100894-1-Centricity
PACS-IW-00558200
10994-1-Centricity
PACS-IW-00558177
100898-1-Centricity
PACS-IW-00558176
100895-1-Centricity
PACS-IW-00558195
100823-1-Centricity
PACS-IW-00558175
100901-1-Centricity
PACS-IW-00558151
100762-1-Centricity
PACS-IW-01225872
100902-1-Centricity
PACS-IW-00558180
100905-1-Centricity
PACS-IW-00558181
100906-1-Centricity
PACS-IW-00558165
100908-1-Centricity
PACS-IW-00558158
100909-1-Centricity
PACS-IW-00558198
100910-1-Centricity
PACS-IW-00558178
100911-1-Centricity
PACS-IW-00558160
100912-1-Centricity
PACS-IW-00558161
100916-1-Centricity
PACS-IW-00558199
100917-1-Centricity
PACS-IW-00558185
100918-1-Centricity
PACS-IW-00558156
PACS-IW-00000542 (b) 2049588-008Serial
Numbers
388 of 388 codes
101039-1-Centricity
PACS-IW-00558550
101042-1-Centricity
PACS-IW-00558386
100821-1-Centricity
PACS-IW-00558325
100674-1-Centricity
PACS-IW-00558486
100663-1-Centricity
PACS-IW-00558514
101156-1-Centricity
PACS-IW-00558446
101181-1-Centricity
PACS-IW-00558467
1565-1-Centricity
PACS-IW-00603058
101193-1-Centricity
PACS-IW-00558551
10884-2-Centricity
PACS-IW-00558100
11042-1-Centricity
PACS-IW-00558368
101240-1-Centricity
PACS-IW-00558425
3571-1-Centricity
PACS-IW-00558468
101310-1-Centricity
PACS-IW-00558552
101625-1-Centricity
PACS-IW-00558531
4684-1-Centricity
PACS-IW-00558245
101647-1-Centricity
PACS-IW-00558515
4424-1-Centricity
PACS-IW-00558429
101171-1-Centricity
PACS-IW-00558310
101689-1-Centricity
PACS-IW-00558326
101883-1-Centricity
PACS-IW-00558487
101932-1-Centricity
PACS-IW-00558495
101792-1-Centricity
PACS-IW-00558370
101742-1-Centricity
PACS-IW-00558470
4734-1-Centricity
PACS-IW-00558375
4424-1-Centricity
PACS-IW-00558429
4573-1-Centricity
PACS-IW-00558420
4353-1-Centricity
PACS-IW-00558273
4256-1-Centricity
PACS-IW-00558250
4553-1-Centricity
PACS-IW-00558327
ONCOLOGY-Centricity
PACS-IW-01288658
85021-Centricity
PACS-IW-00006698
06002-Centricity
PACS-IW-00115199
00001-Centricity
PACS-IW-00164412
529010-Centricity
PACS-IW-00000342
651948-Centricity
PACS-IW-00000422
941804-Centricity
PACS-IW-00000474
150010-Centricity
PACS-IW-00000213
YP5673-Centricity
PACS-IW-00045220
FP5028-Centricity
Universal
73 of 73 codes
Viewer-00110911
YP3150-Centricity
PACS-IW-00045222
YP3150-Centricity
PACS-IW-00045224
UP506-Centricity
PACS-IW-00044759
ZA2501-Centricity
PACS-IW-00162756
ZA2315-Centricity
PACS-IW-00111417
ZA2372-Centricity
PACS-IW-00111415
ZA2401-Centricity
PACS-IW-00116562
ZA2402-Centricity
PACS-IW-00116561
ZA2474-Centricity
PACS-IW-00116763
ZA2338-Centricity
PACS-IW-00116588
ZA2339-Centricity
PACS-IW-00116589
ZA2409-Centricity
PACS-IW-00116591
ZA2408-Centricity
PACS-IW-00116590
ZA2410-Centricity
PACS-IW-00116592
ZA2414-Centricity
PACS-IW-00116438
ZA2415-Centricity
PACS-IW-00116440
ZA2353-Centricity
PACS-IW-00116567
ZA2471-Centricity
PACS-IW-00116573
ZA2351-Centricity
PACS-IW-00116569
ZA2470-Centricity
PACS-IW-00116572
ZA2352-Centricity
PACS-IW-00116570
ZA2267-Centricity
PACS-IW-00116765
ZA2356-Centricity
PACS-IW-00116576
ZA2355-Centricity
PACS-IW-00116575
ZA2336-Centricity
PACS-IW-00116448
ZA2331-Centricity
PACS-IW-00116443
ZA2335-Centricity
PACS-IW-00116447
ZA2330-Centricity
PACS-IW-00116442
ZA2334-Centricity
PACS-IW-00116446
SI4014-Centricity
SA 1175-Centricity PACS-IW-00065872 SA2294-Centricity PACS-IW-00065843 SA 2281-Centricity PACS-IW-00065865 SA
260 of 260 codes
1025-Centricity
PACS-IW-00065854
SA1126-Centricity
PACS-IW-00065887
SA2187-Centricity
PACS-IW-00065875
SA1198-Centricity
PACS-IW-00065868
SA1052-Centricity
PACS-IW-00065793
SA1175-Centricity
PACS-IW-00038187
SA2281-Centricity
PACS-IW-00038161
600100-Centricity
PACS-IW-01273193
RU1241-Centricity
PACS-IW-01273216
RU1493-Centricity
PACS-IW-01273220
RU2967-Centricity
PACS-IW-01273244
RU5302-Centricity
PACS-IW-01273274
RU2420-Centricity
PACS-IW-01273234
RU3910-Centricity
PACS-IW-01273270
RU3262-Centricity
PACS-IW-01273245
RU6248-Centricity
PACS-IW-01273279
RU1648-Centricity
PACS-IW-01273222
RU8071-Centricity
PACS-IW-01273295
RU6340-Centricity
PACS-IW-01273280
RU8041-Centricity
PACS-IW-01273294
RU7576-Centricity
PACS-IW-01273287
RU3880-Centricity
PACS-IW-01273266
RU3894-Centricity
PACS-IW-01273269
RU3564-Centricity
PACS-IW-01273252
RU8162-Centricity
PACS-IW-01273299
RU2527-Centricity
PACS-IW-01273235
RU5310-Centricity
PACS-IW-01273276
RU3959-Centricity
PACS-IW-01273273
RU2878-Centricity
PACS-IW-01273243
RU1050-Centricity
PACS-IW-00167296
MYHEALTH-Centricity PACS-IW-01819534 StLukes-Centricity PACS-IW-01286216 NG1043-IW w UW Base SW
PVP-00158638
AMS39-Centricity
PACS-IW-00044104
BON01-Centricity
PACS-IW-00044128
BON01-Centricity
PACS-IW-00044129
ECT02-Centricity
PACS-IW-00044114
HRL09-Centricity
PACS-IW-00044099
UMUM-Centricity PACS-IW-01288666 SSH-Centricity PACS-IW-01288660 BEVERLY-Centricity PACS-IW-01288659 REGENCY-Centricity PACS-IW-01286180 MAHKOTA-Centricity
PACS-IW-01286179
LB1331-Centricity
PACS-IW-00116959
KW1019-Centricity
PACS-IW-00115173
KW1018-Centricity
PACS-IW-00168151
KW1112-Centricity
PACS-IW-01422962
KW1102-Centricity
PACS-IW-00603360
KW1013-Centricity
PACS-IW-00115175
KW1096-Centricity
PACS-IW-00166324
KW1003-Centricity
PACS-IW-01798078
KW1001-Centricity
PACS-IW-00164288
KW1001-Centricity
PACS-IW-00164707
1971565-YUHSSC-RAD-Centricity
PACS-IW-01819454
KANGBUK-Centricity PACS-IW-01819442 CHILGOK-Centricity PACS-IW-01819441 PUSANPAIK-Centricity
PACS-IW-01819440
00000171164II7
00000215840II0
00000201878II6
00000201701II0
00000171163II9
00000215827II7
JP-080145-Centricity
PACS-IW-01275208
00000191437II3
00000191304II5
00000189620II8
00000201750II7
00000190384II8
00000201777II0
A56306-Centricity
PACS-IW-00040439
A2513980-Centricity
PACS-IW-00040355
A52793-Centricity
PACS-IW-00040430
SODANI-Centricity PACS-IW-01819445 WOCKHARDT-Centricity PACS-IW-01819449 ApolloBSR-Centricity PACS-IW-01819452 SIMS-Centricity PACS-IW-01819453 CONTINENTAL-Centricity PACS-IW-01819443 CTSI-Centricity PACS-IW-01819444 MARTHANDAM-Centricity PACS-IW-01819446 StThomas-Centricity
125 of 125 codes
PACS-IW-01819447
HU1025-Centricity
PACS-IW-00038776
HU1008-Centricity
PACS-IW-00038775
HU1036-Centricity
PACS-IW-00038777
HU1469-Centricity
PACS-IW-00038785
HU1038-Centricity
PACS-IW-00038778
HU1093-Centricity
PACS-IW-00038784
HU1397-Centricity
PACS-IW-00038782
HU1041-Centricity
PACS-IW-00038780
HU1039-Centricity
PACS-IW-00038779
HU1185-Centricity
PACS-IW-00038781
HU1433-Centricity
PACS-IW-00038783
HC9080-Centricity
PACS-IW-00001567
714235-Centricity
PACS-IW-00000842
363691-Centricity
PACS-IW-00000520
786787-Centricity
PACS-IW-00000850
424881-Centricity
PACS-IW-00000556
622328-Centricity
PACS-IW-00000799
HC0529-Centricity
PACS-IW-00001052
HC0098-Centricity
PACS-IW-00001010
HC4357-Centricity
PACS-IW-00001419
RMUE01-Centricity
PACS-IW-00001801
HBON01-Centricity
PACS-IW-00000966
CC0154-Centricity
PACS-IW-00000866
972439-Centricity
PACS-IW-00000859
691749-Centricity
PACS-IW-00000833
683198-Centricity
PACS-IW-00000826
PC0125-Centricity
PACS-IW-00001683
PX4900-Centricity
PACS-IW-00001799
600791-Centricity
PACS-IW-00000776
UHAM02-Centricity
SiteID-Centricity
PACS-IW-01422973
313689-Centricity
PACS-IW-01431524
319674-Centricity
PACS-IW-01431535
319674-Centricity
PACS-IW-01431535
BA4080-Centricity
PACS-IW-00038769
80083-Centricity
PACS-IW-00043981
BH1038-Centricity
PACS-IW-00162931
AP6469-Centricity
PACS-IW-00000183
DZ1004-Centricity
PACS-IW-00116835
Amount recalled: 569 units

Where it was sold

Nationwide

Why it was recalled

A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. There is a potential that one or more image series (i.e. all images within an image set) may be missing from an exam without indication to the user. While this is rare, this can occur with imaging studies that consist of a very small number of images per series. E.g. CR Thorax exam with 1 image per series.

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

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

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37 in total.

All recall categories · Browse the whole archive