Recall Z-0768-2024— Getinge Usa Sales Inc

Name: FDA recall Z-0768-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-08

Class II · Ongoing

Class II FDA medical device recall by Getinge Usa Sales Inc, initiated 2023-11-08. It names one FDA 510(k) clearance: K932451. Product: 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: 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

510(k) clearances named in this recall

1 on FDA's record

K932451 — HANAULUX 2005 SURGICAL LIGHTHeraeus Instruments GmbH·cleared 1993-11-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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