Azurion 7 M20 FlexArm system — Class II medical device recall Z-0861-2024
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2024-02-07, distributed nationwide. Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format
| Recall number | Z-0861-2024 |
|---|---|
| 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 | 2023-12-08 |
| Classified | 2024-01-30 |
| Reported by FDA | 2024-02-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838085268, 00884838099258 |
| Serial numbers | 1005, 1122, 1135, 1169, 1172, 1202, 1216, 1241, 1303, 1313, 1332, 134, 1357, 1361, 1388, 1421, 1431, 144, 1463, 150, 157, 1589, 1655, 1667, 1700 and 74 more |
Product
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Reason for recall
Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format. This connection issue leads to a loss of movement of the arm or table.
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-0861-2024. 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.