FDA Enforcement
Class II
Ongoing
Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C
Recall: Z-0769-2024
·
Reported January 24, 2024
Enforcement
- Recall Number
- Z-0769-2024
- Event ID
- 93567
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Getinge Usa Sales Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 24, 2024
- Initiation Date
- November 8, 2023
- Classification Date
- January 18, 2024
- Address
- 1 Geoffrey Way, N/A, Wayne, NJ, 07470-2035, United States
Description
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.
Code Info
All systems affected
Distribution
US Nationwide. Global Distribution.
Quantity
236793 units in total