Philips Allura — Class II medical device recall Z-0874-2022
Ongoing recall by Philips North America Llc, reported 2022-04-13, distributed nationwide. Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run a
| Recall number | Z-0874-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2022-02-02 |
| Classified | 2022-04-06 |
| Reported by FDA | 2022-04-13 |
| Distributed | Nationwide (US) |
| Quantity | 338 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00459801781661, 00884838054189, 00884838054196, 00884838054202, 00884838054219, 00884838054240, 00884838059030, 00884838059054, 00884838085251, 00884838085268, 00884838085275, 00884838085282, 00884838085350, 00884838085367, 00884838099203, 00884838099210, 00884838099227, 00884838099234, 00884838099241, 00884838099258, 00884838099265, 00884838099272 |
| Serial numbers | 1003, 1005, 1013, 1025, 107, 110, 1105, 114, 115, 117, 118, 1199, 120, 1209, 121, 123, 1250, 126, 129, 131, 132, 137, 139, 1391, 140 and 191 more |
| Model numbers | 459801781661, 722010, 722012, 722026, 722027, 722028, 722029, 722035, 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228 |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0874-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.