FDA recall Z-0765-2024

Getinge Usa Sales Inc · Class II · device

Product

Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C

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-0765-2024