Philips Azurion — Class II medical device recall Z-2170-2026
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2026-05-20, distributed nationwide. Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor c
| Recall number | Z-2170-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, Netherlands |
| Recall initiated | 2026-03-31 |
| Classified | 2026-05-12 |
| Reported by FDA | 2026-05-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,718 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884838085251, 00884838085367, 00884838099203, 00884838099210, 00884838099227, 00884838099234, 00884838099241, 00884838099258, 00884838099265, 00884838099272, 00884838110564, 00884838110571, 00884838116726, 00884838116733, 00884838116740, 00884838116757, 00884838116764, 00884838116771, 00884838116788, 00884838116801 |
Product
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).
Reason for recall
Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.
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-2170-2026. 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.