Agency classClass IIOur severity:High FDA (Devices)·Z-0764-2024·Announced 2024-01-24

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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…
Manufacturer: Getinge Usa Sales Inc
Category: Medical Device — Operating Room Lighting
Hazard: fall-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.

See all 15 products in this recall →

Same manufacturer · Getinge Usa Sales Inc

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Same hazard · fall hazard