Maquet Operating Room Light Systems Recalled Due to Fall Risk
Getinge USA Sales Inc is recalling Maquet Equipment OR Light Systems due to a potential risk that the light systems could fall in the operating room. Approximately 236,793 units have been distributed.
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 recall with a theoretical hazard—a potential for light systems to fall in operating rooms. Although there are no reported illnesses or injuries, the risk-of-harm nature of a falling surgical OR light in an active operating room environment justifies a High severity rating.
Plain-English summary
Getinge USA Sales Inc is recalling multiple Maquet Equipment OR Light Systems models used in operating rooms. The recalled equipment includes various configurations designated with catalog numbers such as BRAINLAB CAMERA (multiple SKUs), EQTBRB SAT12, EQTFHS010, EQTMHD231, EQTMHS013, EQTMHS021, EQTSC07, and EQTSPC12, among others.
The FDA issued a Class II recall due to a potential for the light systems to fall in the operating room.
Approximately 236,793 units have been distributed nationwide in the United States and globally. The systems are identified by specific UDI-DI (Unique Device Identification) codes documented in the FDA database.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA - ARDEQT269000C, BRAINLAB CAMERA - ARDEQT269001A, BRAINLAB CAMERA - ARDEQT269001C, BRAINLAB CAMERA - ARDEQT269004A, BRAINLAB CAMERA - ARDEQT269004C, BRAINLAB…
- 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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