Maquet PowerLEDII Operating Room Light System Recalled for Fall Risk
Getinge Usa Sales Inc is recalling Maquet PowerLEDII OR light systems due to a potential for the light to fall in the operating room. No injuries have been reported.
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: This is a Class II FDA recall of operating room equipment with a potential to fall during surgical procedures. Although no injuries have been reported, the potential for equipment failure in a critical care setting represents a significant risk of harm to patients and surgical staff, meeting the criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Getinge Usa Sales Inc is recalling all Maquet PowerLEDII OR (operating room) light systems. The recall affects a total of 236,793 units across multiple model variations.
The recalled systems have a potential to fall in the operating room. This poses a risk in the surgical environment.
The affected units have been distributed nationwide in the United States and globally. No injuries or illnesses have been reported in association with this recall.
The recalled product
- Product
- Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - ARDPWT629102A, PWDII755DF - ARDPWT629103A, PWDII755SF - ARDPWT629104A, PWDII775DF - ARDPWT629105A, PWDII775SF - ARDPWT629106A, PWDII50DF - ARDPWT
- Manufacturer
- Getinge Usa Sales Inc
- Category
- Medical Device
- Hazard
- fall-hazard
- injury-risk
Distribution
Distributed nationwide across the United States.
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