FDA-Device2024-01-24Class II

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 - AR

Getinge Usa Sales Inc

Hazard

A potential for a light system to fall in the operating room.

Sold states

US Nationwide. Global Distribution.

Affected count

236793 units in total

Manufactured in

1 Geoffrey Way, N/A, Wayne, NJ, United States

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0764-2024

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