Device 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
Z-0764-2024
Product summary
- Event
- Event 93567
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 236793 units in total
- Official record key
device-enforcement:Z-0764-2024
Official wording
Reason: A potential for a light system to fall in the operating room.
Code information: All systems affected
Distribution pattern: US Nationwide. Global Distribution.
Derived failure modes
-
Unknown
A potential for a light system to fall in the operating room.