Recall Z-0769-2024— 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 G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C. 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 G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C
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.