RecallRadar

FDA Device recall Z-0765-2024

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

On 2024-01-24 the FDA classified a Class II recall of Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C by Getinge Usa Sales, citing A potential for a light system to fall in the operating room.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0765-2024
ClassificationClass II
Statusongoing
Initiated2023-11-08
Published2024-01-24
Last updated2026-09-13 11:57 UTC
CompanyGetinge Usa Sales
DistributionUS

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.

Identifiers

code_infoAll systems affected

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0765-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.