FDA Enforcement Class II Ongoing

Maquet Prismalix 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

Recall: Z-0767-2024 · Reported January 24, 2024

Enforcement

Recall Number: Z-0767-2024
Event ID: 93567
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: Getinge Usa Sales Inc
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: January 24, 2024
Initiation Date: November 8, 2023
Classification Date: January 18, 2024
Address: 1 Geoffrey Way, N/A, Wayne, NJ, 07470-2035, United States

Description

Reason

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

Code Info

All systems affected

Distribution

US Nationwide. Global Distribution.

Quantity

236793 units in total