Getinge Usa Sales Inc: Medical Device Recall in 2024 - (Recall #: Z-0764-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: November 8, 2023

Date Posted: January 24, 2024

Recall Number: Z-0764-2024

Event ID: 93567

Reason for Recall:

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

Status: Ongoing

Product Quantity: 236793 units in total

Code Information:

All systems affected

Distribution Pattern:

US Nationwide. Global Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated