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.
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 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…
- Manufacturer
- Getinge Usa Sales Inc
- Category
- Medical Device
- 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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