CLASS II ONGOING Device recall · Reported 13 Apr 2022 · FDA Enforcement Report
Philips Allura recalled by Philips North America
Philips North America is recalling Philips Allura (, distributed nationwide in the US. The recall was initiated on 2 Feb 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0874-2022
- FDA event ID
- 89787
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Feb 2022
- FDA classified
- 6 Apr 2022
- Reported
- 13 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 2 Feb 2022 | Recall initiated by company | |
| 6 Apr 2022 | Classified by FDA | +63 days |
| 13 Apr 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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 Number: R2.0
Where it was distributed
Global Distribution. US Nationwide.
Questions about this recall
Is Philips Allura ( recalled?
Yes. Philips North America recalled Philips Allura ( on 2 Feb 2022. The recall is Class II and its status is Ongoing. Recall number Z-0874-2022.
Why was it 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.
Which lots are affected?
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 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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
Where was it sold?
Global Distribution. US Nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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