Recall Z-0762-2024— Getinge Usa Sales Inc
Class II · Ongoing
Class II FDA medical device recall by Getinge Usa Sales Inc, initiated 2023-11-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: A potential for a light system to fall in the operating room..
- Recalling firm
- Getinge Usa Sales Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-08
- Firm location
- Wayne, NJ, United States
Product description
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
Reason for recall
A potential for a light system to fall in the operating room.
Data sourced from openFDA. This site is unofficial and independent of the FDA.