Philips Azurion 7M20 systems with FlexArm ceiling-mounted system — Class II medical device recall Z-2953-2024
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2024-09-11, distributed nationwide. The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may b
| Recall number | Z-2953-2024 |
|---|---|
| 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 | 2024-08-06 |
| Classified | 2024-09-04 |
| Reported by FDA | 2024-09-11 |
| Distributed | Nationwide (US) |
| Quantity | 927 systems |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00884838085268, 00884838099258 |
| Serial numbers | 1003, 1004, 1005, 1006, 101, 1018, 1024, 1032, 1037, 1040, 1041, 1043, 1046, 1049, 1059, 1063, 1064, 1081, 1082, 1083, 1084, 1086, 1091, 1098, 1102 and 391 more |
| Model numbers | 722079, 722224 |
Product
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
Reason for recall
The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel.
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-2953-2024. 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.