Surgical Light Systems Recalled Due to Fall Hazard Risk
Maquet Lucea operating room light systems are being recalled 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 medical device recall involving a risk-of-harm product (falling surgical light) where no injuries or deaths have been reported. The potential for impact injuries in the operating room meets the criterion for High severity.
Plain-English summary
Getinge Usa Sales Inc is recalling Maquet Lucea operating room light systems due to a potential for the light system to fall in the operating room. The recall affects approximately 236,793 units distributed nationwide in the United States and globally.
The recalled light systems include multiple models including LCA 10, LCA 40, LCA 50, LCA 100, and various configurations (mobile, wall-mounted, and dual systems). If a light system falls, it could cause injury to patients, surgical staff, or other healthcare personnel in the operating room.
Healthcare facilities using these light systems should immediately inspect and secure all installations. Any facilities that have experienced incidents involving these light systems should report them to the FDA and the manufacturer. Facilities should contact Getinge Usa Sales Inc for further information or corrective actions.
The recalled product
- Product
- Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 10 - ARDLCA109000C, LCA 10 - ARDLCA109002C, LCA 10 - ARDLCA109006C, LCA 10 - ARDLCA209008A, LCA 10 - ARDLCA209008C, LCA 10 - ARDLCA209009A, LCA 10…
- 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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