PlainRecalls
FDA Devices Moderate Class II Ongoing

Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211C, 4001 SAD/DF - ARD567221241C, 4001 SAD/SF - ARD567221141C, 4001 SAI/DF - ARD567220111C, 4001K S/DF - ARD567211213C, 4003 - ARD567215111C, 4401 S/DF - ARD567212211C, 4401 SAD/DF - ARD567223211C, 4401 SAD/DF - ARD567223241C, 4401 SAD/SF - ARD567223111C, 4441 SAD/DF - ARD567225241C, 6001K ACS/

Reported: January 24, 2024 Initiated: November 8, 2023 #Z-0768-2024

Product Description

Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211C, 4001 SAD/DF - ARD567221241C, 4001 SAD/SF - ARD567221141C, 4001 SAI/DF - ARD567220111C, 4001K S/DF - ARD567211213C, 4003 - ARD567215111C, 4401 S/DF - ARD567212211C, 4401 SAD/DF - ARD567223211C, 4401 SAD/DF - ARD567223241C, 4401 SAD/SF - ARD567223111C, 4441 SAD/DF - ARD567225241C, 6001K ACS/T - ARD567234113C, 6001K SAL/T - ARD567226113C, 6101 ACS/SU - ARD567235001C, 6301 SAL/T - ARD567423111C, 6401 ACS/DF - ARD567235211C, 6401 ACS/DF - ARD567235231C, 6401 ACS/DF - ARD567235241C, 6401 SAL/DF - ARD567227211C, 6401 SAL/DF - ARD567227241C, 6401K ACS/D - ARD567235243C, 6401K SAL/SF - ARD567227113C, 6411 SAL/DF - ARD567228009C, 6441 ACS/DF - ARD567236241C, 8401 ACS/DF - ARD567231225C, 8401 ACS/DF - ARD567231241C, 8401K ACS/D - ARD567231243C, 8431 ACS/DF - ARD567431221C, 8431 ACS/DF - ARD567431241C, 8441 ACS/DF - ARD567232241C, PRISMALIX - ARD567761211C

Reason for Recall

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

Details

Recalling Firm
Getinge Usa Sales Inc
Units Affected
236793 units in total
Distribution
US Nationwide. Global Distribution.
Location
Wayne, NJ

Frequently Asked Questions

What product was recalled?
Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211C, 4001 SAD/DF - ARD567221241C, 4001 SAD/SF - ARD567221141C, 4001 SAI/DF - ARD567220111C, 4001K S/DF - ARD567211213C, 4003 - ARD567215111C, 4401 S/DF - ARD567212211C, 4401 SAD/DF - ARD567223211C, 4401 SAD/DF - ARD567223241C, 4401 SAD/SF - ARD567223111C, 4441 SAD/DF - ARD567225241C, 6001K ACS/T - ARD567234113C, 6001K SAL/T - ARD567226113C, 6101 ACS/SU - ARD567235001C, 6301 SAL/T - ARD567423111C, 6401 ACS/DF - ARD567235211C, 6401 ACS/DF - ARD567235231C, 6401 ACS/DF - ARD567235241C, 6401 SAL/DF - ARD567227211C, 6401 SAL/DF - ARD567227241C, 6401K ACS/D - ARD567235243C, 6401K SAL/SF - ARD567227113C, 6411 SAL/DF - ARD567228009C, 6441 ACS/DF - ARD567236241C, 8401 ACS/DF - ARD567231225C, 8401 ACS/DF - ARD567231241C, 8401K ACS/D - ARD567231243C, 8431 ACS/DF - ARD567431221C, 8431 ACS/DF - ARD567431241C, 8441 ACS/DF - ARD567232241C, PRISMALIX - ARD567761211C. Recalled by Getinge Usa Sales Inc. Units affected: 236793 units in total.
Why was this product recalled?
A potential for a light system to fall in the operating room.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 24, 2024. Severity: Moderate. Recall number: Z-0768-2024.