FDA Enforcement
Class II
Ongoing
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
Recall: Z-0762-2024
·
Reported January 24, 2024
Enforcement
- Recall Number
- Z-0762-2024
- 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 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.
Code Info
All systems affected UDI-DI: 3700712415761 3700712415976 3700712418274 3700712418281 3700712412340
Distribution
US Nationwide. Global Distribution.
Quantity
236793 units in total