Maquet G8 Operating Room Light Systems Recalled for Fall Risk
Getinge USA is recalling Maquet G8 and G8E operating room light systems that may fall during use. Approximately 236,793 units have been distributed nationwide and globally.
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 an FDA Class II medical device recall for a risk-of-harm product (operating room light system with fall risk) where no injuries have been reported. Per the severity rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
Getinge USA is recalling Maquet G8 and G8E operating room light systems. The affected models include G8 LC E (ARD568131211C), G8G8 DF E (ARD568121111C), and G8G8FS DF (ARD568121131C).
These light systems present a potential for the unit to fall in the operating room, creating a hazard in clinical environments.
Approximately 236,793 units have been distributed nationwide in the United States and globally.
The recalled product
- Product
- Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C
- Manufacturer
- Getinge Usa Sales Inc
- Hazard
- fall-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All systems affected
Distribution
Distributed nationwide across the United States.
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