Reported Apr 13, 2022 · Ongoing

Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model…

Philips North America LLC

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: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289

Is this the product you have?

Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661)
Software Version NumberR2.0

Lot codes and dates: UDI(01)00884838059030(21)839 (01)00884838085275(21)131 (01)00884838059054(21)577 (01)00884838085350(21)81 (01)00884838085367(21)271 (01)00884838054202(21)879 (01)00884838054202(21)1783 (01)00884838054202(21)1447 (01)00884838099241(21)282 (01)00884838099258(21)512 (01)00884838099258(21)360 (01)00884838099258(21)370 (01)00884838099258(21)584 (01)00884838099272(21)239 (01)00884838099258(21)425 (01)00884838099258(21)232 (01)00884838099258(21)591 (01)00884838099258(21)580 (01)00884838099258(21)39 (01)00884838099241(21)198 (01)00884838099258(21)589 (01)00884838099258(21)362 (01)00884838085268(21)954 (01)00884838099234(21)10 (01)00884838099241(21)214 (01)00884838099272(21)183 (01)00884838099258(21)526 (01)00884838099258(21)441 (01)00884838099272(21)121 (01)00884838099258(21)80 (01)00884838099258(21)326 (01)00884838099258(21)518 (01)00884838099258(21)404 (01)00884838099241(21)252 (01)00884838099258(21)453 (01)00884838099258(21)472 (01)00884838099258(21)465 (01)00884838099272(21)129 (01)00884838099272(21)174 (01)00884838099258(21)553 (01)00884838099258(21)517 (01)00884838099258(21)400 (01)00884838099258(21)342 (01)00884838099258(21)582 (01)00884838099241(21)196 (01)00884838085268(21)1391 (01)00884838099258(21)485 (01)00884838099258(21)262 (01)00884838099258(21)277 (01)00884838099272(21)120 (01)00884838085268(21)703826 (01)00884838085367(21)38 (01)00884838085367(21)36 (01)00884838085275(21)139 (01)00884838085268(21)1199 (01)00884838085251(21)940 (01)00884838085251(21)945 (01)00884838085251(21)947 (01)00884838085268(21)703680 (01)00884838085251(21)964 (01)00884838085268(21)703724 (01)00884838085268(21)703541 (01)00884838085268(21)703815 (01)00884838085251(21)991 (01)00884838085251(21)1013 (01)00884838085251(21)943 (01)00884838085251(21)1025 (01)00884838085282(21)417 (01)00884838054202(21)511 (01)00884838085268(21)559 (01)00884838085268(21)560 (01)00884838085268(21)340 (01)00884838085350(21)45 (01)00884838085268(21)703560 (01)00884838054202(21)810 (01)00884838085350(21)272 (01)00884838085350(21)256 (01)00884838054189(21)364 (01)00884838054189(21)164 (01)00884838054189(21)1250 (01)00884838059030(21)226 (01)00884838059030(21)860 (01)00884838054189(21)1105 (01)00884838085251(21)464 (01)00884838085268(21)703523 (01)00884838085268(21)703524 (01)00884838085268(21)1418 (01)00884838085268(21)1209 (01)00884838085268(21)1427 (01)00884838085268(21)703537 (01)00884838085268(21)703538 (01)00884838085268(21)703517 (01)00884838085268(21)1426 (01)00884838054202(21)305 (01)00884838054196(21)139 (01)00884838085251(21)1003 (01)00884838085251(21)207 (01)00884838085251(21)209 (01)00884838085251(21)211 (01)00884838085251(21)447 (01)00884838085268(21)232 (01)00884838054189(21)412 (01)00884838054202(21)1547 (01)00884838054219(21)59 (01)00884838054240(21)92 (01)00884838085251(21)1005 (01)00884838085251(21)220 (01)00884838085251(21)799 (01)00884838099258(21)221 (01)00884838099227(21)62 (01)00884838099241(21)201 (01)00884838099241(21)185 (01)00884838099258(21)145 (01)00884838099258(21)257 (01)00884838099258(21)352 (01)00884838099258(21)353 (01)00884838099272(21)141 (01)00884838099258(21)368 (01)00884838099241(21)132 (01)00884838099241(21)165 (01)00884838099241(21)117 (01)00884838099241(21)195 (01)00884838099258(21)555 (01)00884838099241(21)267 (01)00884838099241(21)268 (01)00884838099241(21)271 (01)00884838099241(21)270 (01)00884838099241(21)255 (01)00884838099241(21)224 (01)00884838099227(21)56 (01)00884838099241(21)287 (01)00884838099241(21)114 (01)00884838099258(21)67 (01)00884838099241(21)239 (01)00884838099241(21)249 (01)00884838099241(21)141 (01)00884838099258(21)783 (01)00884838099258(21)531 (01)00884838099227(21)28 (01)00884838099241(21)142 (01)00884838099241(21)235 (01)00884838099241(21)227 (01)00884838085268(21)703959 (01)00884838099258(21)600 (01)00884838099241(21)348 (01)00884838099241(21)176 (01)00884838099258(21)634 (01)00884838099241(21)321 (01)00884838099241(21)123 (01)00884838099227(21)32 (01)00884838099227(21)72 (01)00884838099203(21)8 (01)00884838099227(21)64 (01)00884838099234(21)46 (01)00884838099241(21)91 (01)00884838099227(21)2 (01)00884838099265(21)4 (01)00884838099241(21)95 (01)00884838099241(21)283 (01)00884838099234(21)21 (01)00884838099234(21)22 (01)00884838099241(21)295 (01)00884838099272(21)140 (01)00884838099227(21)5 (01)00884838099227(21)6 (01)00884838099227(21)7 (01)00884838099227(21)74 (01)00884838099241(21)218 (01)00884838099265(21)38 (01)00884838099227(21)40 (01)00884838099227(21)15 (01)00884838099272(21)166 (01)00884838099227(21)47 (01)00884838099227(21)48 (01)00884838099227(21)13 (01)00884838099241(21)140 (01)00884838099241(21)9 (01)00884838099241(21)49 (01)00884838099241(21)20 (01)00884838099241(21)157 (01)00884838099258(21)597 (01)00884838099258(21)810 (01)00884838099272(21)171 (01)00884838099258(21)413 (01)00884838099241(21)76 (01)00884838085268(21)304 (01)00884838099203(21)48 (01)00884838099210(21)27 (01)00884838099258(21)270 (01)00884838099227(21)52 (01)00884838099258(21)416 (01)00884838099203(21)45 (01)00884838099241(21)291 (01)00884838099258(21)535 (01)00884838099272(21)86 (01)00884838099258(21)576 (01)00884838099258(21)345 (01)00884838099258(21)198 (01)00884838099258(21)126 (01)00884838099258(21)457 (01)00884838099258(21)117 (01)00884838099258(21)241 (01)00884838099258(21)510 (01)00884838099241(21)86 (01)00884838099265(21)60 (01)00884838099265(21)76 (01)00884838099258(21)168 (01)00884838099272(21)157 (01)00884838099258(21)137 (01)00884838085268(21)893 (01)00884838099258(21)473 (01)00884838099265(21)77 (01)00884838099265(21)20 (01)00884838099258(21)397 (01)00884838099272(21)73 (01)00884838099241(21)107 (01)00884838099258(21)392 (01)00884838099234(21)30 (01)00884838099272(21)137 (01)00884838099203(21)11 (01)00884838099265(21)67 (01)00884838099272(21)210 (01)00884838099265(21)64 (01)00884838099272(21)77 (01)00884838099258(21)142 (01)00884838099265(21)80 (01)00884838099241(21)166 (01)00884838099265(21)70 (01)00884838099272(21)28 (01)00884838099265(21)75 (01)00884838099272(21)192 (01)00884838099272(21)193 (01)00884838099234(21)27 (01)00884838099265(21)57 (01)00884838099258(21)692 (01)00884838099272(21)110 (01)00884838099265(21)34 (01)00884838099272(21)91 (01)00884838099241(21)200 (01)00884838099272(21)43 (01)00884838099272(21)161 (01)00884838099265(21)69 (01)00884838099265(21)61 (01)00884838099265(21)63 (01)00884838099258(21)157 (01)00884838099241(21)184 (01)00884838099265(21)13 (01)00884838099272(21)46 (01)00884838099265(21)59 (01)00884838099265(21)117 (01)00884838099258(21)197 (01)00884838099265(21)58 (01)00884838099265(21)18 (01)00884838099265(21)92 (01)00884838099258(21)144 (01)00884838099258(21)212 (01)00884838099265(21)42 (01)00884838099272(21)283 (01)00884838099241(21)82 (01)00884838085268(21)703810 (01)00884838099258(21)375 (01)00884838099241(21)170 (01)00884838099241(21)4 (01)00884838099272(21)118 (01)00884838099241(21)1534 (01)00884838099241(21)118 (01)00884838099258(21)358 (01)00884838099258(21)508 (01)00884838099258(21)499 (01)00884838099258(21)530 (01)00884838099272(21)203 (01)00884838099210(21)37 (01)00884838099258(21)549 (01)00884838099203(21)15 (01)00884838099258(21)348 (01)00884838085268(21)703461 (01)00884838099241(21)263 (01)00884838099241(21)263 (01)00884838099241(21)159 (01)00884838099241(21)160 (01)00884838099258(21)211 (01)00884838099258(21)474 (01)00884838099227(21)35 (01)00884838099241(21)309 (01)00884838099241(21)315 (01)00884838099241(21)110 (01)00884838099258(21)243 (01)00884838099258(21)610 (01)00884838099258(21)542 (01)00884838099241(21)305 (01)00884838099272(21)233 (01)00884838099272(21)88 (01)00884838099258(21)203 (01)00884838099258(21)604 (01)00884838099241(21)179 (01)00884838099210(21)73 (01)00884838099258(21)698 (01)00884838099258(21)703 (01)00884838099258(21)743 (01)00884838099234(21)65 (01)00884838099241(21)276 (01)00884838099210(21)87 (01)00884838099258(21)751 (01)00884838099272(21)276 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Serial Numbers839 131 577 81
271
879
1783
1447
282
512
360
370
584
239
425
232
591
580
39 198 589 362 954 10 214 183 526 441 121 80
326
518
404
252
453
472
465
129
174
553
517
400
342
582
196
1391
485
262
277
120
703826
38 36
139
1199
940
945
947
703680
964
703724
703541
703815
991
1013
943
1025
417
511
559
560
340
45
703560
810
272
256
364
164
1250
226
860
1105
464
703523
703524
1418
1209
1427
703537
703538
703517
1426
395
139
1003
207
209
211
447
232
412
1547
59 92 1005 220 799 221 62
201
185
145
257
352
353
141
368
132
165
117
195
555
267
268
271
270
255
224
56 287 114 67 239 249 141 783 531 28
142
235
227
703959
600
348
176
634
321
123
32 72 8 64 46 91 2 4 95 283 21 22 295 140 5 6 7 74 218 38 40 15 166 47 48 13 140 9 49 20 157 597 810 171 413 76 304 48 27 270 52 416 45 291 535 86
576
345
198
126
457
117
241
510
86 60 76 168 157 137 893 473 77 20 397 73 107 392 30 137 11 67 210 64 77 142 80 166 70 28 75 192 193 27 57 692 110 34 91 200 43 161 69 61 63 157 184 13 46 59 117 197 58 18 92 144 212 42 283 82 703810 375 170 4
118
1534
118
358
508
499
530
203
37 549 15
348
703461
263
263
159
160
211
474
35
309
315
110
243
610
542
305
233
88 203 604 179 73 698 703 743 65 276 87 751 276 705 701 8 21
537
779
629
631
168
423
456
302
305
310
264
249
386
506
259
248
42 302 8 9 31 87 207 140 551 23 26 178 179 115
Amount recalled: 338

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Nationwide

Why it was recalled

Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from a different patient.

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.

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By hazard

Medical device recalls

Other recalls from Philips North America LLC

Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP.… Sep 9, 2026
Cardiac Workstation 5000. Product Number: 860439. Aug 26, 2026
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A Jul 1, 2026
DigitalDiagnost C90 Flex/Value/Chest/ER. Jun 17, 2026
Brilliance iCT Feb 18, 2026
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. Jan 14, 2026

70 in total.

All recall categories · Browse the whole archive