Maquet Operating Room Light Systems Recalled Due to Fall Hazard
Getinge Usa Sales Inc is recalling 236,793 Maquet operating room light systems nationwide due to a potential for the light system to fall, posing a safety risk to surgical patients and staff.
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 risk-of-harm product (operating room light system with a potential failure mode) where no injury has been reported. FDA Class II designation and the safety-critical nature of the device in a surgical setting justify a High severity score.
Plain-English summary
Getinge Usa Sales Inc is recalling 236,793 Maquet operating room light systems, including the Hanaulux 2006/2007, Blue 100, Blue 130/90, Blue Series 30/80, and Prismatic OR Light Systems. All systems across all models are affected by this recall. The reason for the recall is a potential for the light system to fall in the operating room.
This recall affects hospitals, surgical centers, and other healthcare facilities throughout the United States using these light systems. The potential for the system to fall poses a safety risk to patients undergoing surgery and to surgical and clinical staff working in the operating room.
Healthcare facility managers and personnel using these light systems should contact Getinge Usa Sales Inc immediately for instructions on remediation. Facilities should secure the affected light systems and follow the manufacturer's guidance until the issue has been addressed.
The recalled product
- Product
- Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.
- Manufacturer
- Getinge Usa Sales Inc
- Hazard
- fall-hazard
- trauma-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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