FDA recall Z-0771-2024

Getinge Usa Sales Inc · Class II · device

Product

Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.

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-0771-2024