Maquet Axcel / Axcel + OR Light Systems — Class II medical device recall Z-0764-2024
Ongoing recall by Getinge Usa Sales Inc, reported 2024-01-24, distributed nationwide. A potential for a light system to fall in the operating room.
| Recall number | Z-0764-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Usa Sales Inc, Wayne, NJ, United States |
| Recall initiated | 2023-11-08 |
| Classified | 2024-01-18 |
| Reported by FDA | 2024-01-24 |
| Distributed | Nationwide (US) |
| Quantity | 236,793 units |
| Model numbers | 5001, 5001S, 5002, 5002S, 5501, 5501S, ARD567501960A, ARD567501960C, ARD567501961C, ARD567501962C, ARD567502860C, ARD567502861C, ARD567502930C, ARD567502960C, ARD567502961C, ARD567502971C, ARD567505960C, ARD567505961C, ARD567505962C, ARD567505968C, ARD567505969C, ARDRLC309000C, ARDRLC309006C, AXL5003, AXL5003US and 1 more |
Product
Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD567505961C, AXL 5002 - ARD567501962C, AXL 5002S - ARD567505962C, AXL 5501 - ARD567501960A, AXL 5501 - ARD567501960C, AXL 5501S - ARD567505960C, AXL+5001 DF - ARD567502961C, AXL+5001 SF - ARD567502861C, AXL+5301 DF - ARD567502971C, AXL+5501 DF - ARD567502960C, AXL+5501 SF - ARD567502860C, AXL+5531 DF - ARD567502930C, AXL50 RLC - ARDRLC309000C, AXL50 RLC - ARDRLC309006C, AXL5003 - ARD567505968C, AXL5003 US - ARD567505969C
Reason for recall
A potential for a light system to fall in the operating room.
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-0764-2024. 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.