Home / Recalls / Getinge Usa Sales Inc / Z-0764-2024

Z-0764-2024 Class II Ongoing

Recalled by Getinge Usa Sales Inc — Wayne, NJ

Recall Details

Product Type
Devices
Report Date
January 24, 2024
Initiation Date
November 8, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
236793 units in total

Product Description

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.

Distribution Pattern

US Nationwide. Global Distribution.

Code Information

All systems affected

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