Maquet PowerLED and PowerLED300 Surgical Light Systems Fall Hazard Recall
Getinge recalls 236,793 units of Maquet PowerLED and PowerLED300 operating room light systems due to a potential for the light to fall in the operating room.
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: This FDA Class II recall involves a theoretical equipment-fall hazard in a critical healthcare setting with no reported injuries or deaths. Per the severity rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' which maps to High severity.
Plain-English summary
Getinge Usa Sales Inc has recalled 236,793 units of Maquet PowerLED, HLED, and PowerLED300 operating room light systems.
The recall addresses a potential safety issue: the light system may fall in the operating room. Affected systems include multiple model variants and configurations, identified by specific catalog and model numbers in the FDA recall documentation.
The systems are distributed US nationwide and globally. Healthcare facilities currently using any of the affected model variants should reference the FDA recall notice for the complete list of affected catalog numbers and further information.
The recalled product
- Product
- Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C, EPS MB1 TR - ARDINT059000A, EPS MB1 TR - ARDINT059000C, EPS MB3 - ARDINT059003A, EPS MB3 - ARDINT059003C, EPS MB3 TR - ARDINT059001A, EPS…
- Manufacturer
- Getinge Usa Sales Inc
- Hazard
- Affected units
- 236,793
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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