Recall Z-0765-2024— Getinge Usa Sales Inc

Class II · Ongoing

Class II FDA medical device recall by Getinge Usa Sales Inc, initiated 2023-11-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C. Reason: A potential for a light system to fall in the operating room..

Recalling firm
Getinge Usa Sales Inc
Classification
Class II
Status
Ongoing
Initiated
2023-11-08
Firm location
Wayne, NJ, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.