Maquet Rolite OR Light Systems Recall Due to Fall Risk
Getinge USA is recalling 236,793 Maquet Rolite operating room light systems due to a potential for the light fixture to fall. 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 medical device recall for a risk-of-harm product where no injuries or incidents have been reported. Per the severity rubric, risk-of-harm products without reported injury are rated at most 3 (High).
Plain-English summary
Getinge USA Sales Inc. is recalling Maquet Rolite operating room light systems due to a potential for the light system to fall in the operating room.
The recall involves multiple model numbers and affects 236,793 units distributed nationwide and globally. The light systems have a potential to fall, which could present a hazard to surgical personnel and patients.
No injuries or incidents have been reported in connection with this defect. Customers with affected units should contact Getinge USA Sales Inc. for further information and instructions regarding inspection, repair, or replacement.
The recalled product
- Product
- Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII50SF - ARDPWT309009A, ROL PWDII50SF - ARDPWT309010A, ROL PWDII70SF - ARDPWT309007A, ROL PWDII70SF - ARDPWT309008A, ROL PWDII70SF - ARDPWT309015
- Manufacturer
- Getinge Usa Sales Inc
- Hazard
- fall-risk
Distribution
Distributed nationwide across the United States.
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