FDAFDA · Food and drugs·Recall number Z-0762-2024
Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03 U - ARD568803952, OHDII FHD QL AIR03 E - ARD568803967, OHDII FHD QL AIR04 E/U - ARD568803968, OHDII FHD QL+ VP01 - ARD569204944, OHDII AIR03 QL FHD E - ARD568803951
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 UDI-DI: 3700712415761 3700712415976 3700712418274 3700712418281 3700712412340
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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