Getinge USA Sales Inc. is recalling approximately 3.5 million units of various Maquet-branded operating room light systems because the light system can potentially fall during surgery. This recall affects a wide range of models, including the PowerLEDII, Volista, Lucea, and several older legacy systems. These lights are used in surgical environments and the failure of their mounting or support structures could lead to the light head falling directly onto patients or medical staff.
A defect in the light system's support or mounting structure can cause the heavy surgical lighting to detach and fall in the operating room. This poses a significant risk of impact injuries to patients undergoing surgery or to the healthcare professionals working beneath the units.
Correction and manufacturer notification
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.