FDA recall Z-0762-2024

Getinge Usa Sales Inc · Class II · device

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 for recall

A potential for a light system to fall in the operating room.

Distribution

US Nationwide. Global Distribution.

Key facts

Status
Ongoing
Initiation date
2023-11-08
Report date
2024-01-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0762-2024