FDAFDA · Food and drugs·Recall number Z-0771-2024
Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.
Published January 24, 2024 · Recall initiated: November 8, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A potential for a light system to fall in the operating room.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Getinge Usa Sales Inc
- Distributor
- US Nationwide. Global Distribution.
- Lot
- All systems affected
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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