Maquet Axcel Operating Room Light Systems Recalled for Fall Hazard
The FDA is recalling Maquet Axcel and Axcel+ operating room light systems due to a potential for the light system to fall. The recall affects 236,793 units distributed nationwide and globally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II FDA recall with no reported illnesses or injuries. The hazard—potential for the light system to fall in an operating room—is theoretical with no documented incidents. This qualifies as a risk-of-harm product without reported injury per the rubric.
Plain-English summary
Maquet Axcel and Axcel+ operating room light systems, manufactured by Getinge USA Sales Inc., are subject to a Class II FDA recall. The recalled systems include multiple model numbers including AXL 5001, AXL 5002, AXL 5501, AXL+5001, AXL+5301, AXL+5531, AXL5003, and AXL50 RLC, along with various catalog numbers. A total of 236,793 units have been distributed.
The recall is prompted by a potential for the light system to fall in the operating room. This hazard applies to all systems within the recalled model range.
The affected light systems were distributed nationwide throughout the United States and to locations globally.
The recalled product
- 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 - ARD567
- Manufacturer
- Getinge Usa Sales Inc
- Hazard
- Affected units
- 236,793
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All systems affected
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Getinge Usa Sales Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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