PlainRecalls
FDA Devices Moderate Class II Ongoing

Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII50SF - ARDPWT309009A, ROL PWDII50SF - ARDPWT309010A, ROL PWDII70SF - ARDPWT309007A, ROL PWDII70SF - ARDPWT309008A, ROL PWDII70SF - ARDPWT309015A, ROL PWDII70SF - ARDPWT309016A, ROL VCS40SF - ARDROL309031A, ROL VCS60SF - ARDROL309032A, ROL VST40SF - ARDROL309033A, ROL VST40SF - ARDROL309034A, ROL VST40SF B - ARDROL309037A, ROL VST60SF - ARDROL309035A, ROL VST60S

Reported: January 24, 2024 Initiated: November 8, 2023 #Z-0760-2024

Product Description

Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII50SF - ARDPWT309009A, ROL PWDII50SF - ARDPWT309010A, ROL PWDII70SF - ARDPWT309007A, ROL PWDII70SF - ARDPWT309008A, ROL PWDII70SF - ARDPWT309015A, ROL PWDII70SF - ARDPWT309016A, ROL VCS40SF - ARDROL309031A, ROL VCS60SF - ARDROL309032A, ROL VST40SF - ARDROL309033A, ROL VST40SF - ARDROL309034A, ROL VST40SF B - ARDROL309037A, ROL VST60SF - ARDROL309035A, ROL VST60SF - ARDROL309036A, ROL VST60SF B - ARDROL309038A, ROL VCSII40SF - ARDROL309039A, ROL VCSII40SF - ARDROL309040A, ROL VCSII60SF - ARDROL309041A, ROL VCSII60SF - ARDROL309042A, ROL PWDII50SF - ARDROL309043A, ROL PWDII50SF - ARDROL309044A, ROL PWDII70SF - ARDROL309045A, ROL PWDII70SF - ARDROL309046A, ROL PWDII50SF - ARDROL309047A, ROL PWDII50SF - ARDROL309048A, ROL PWDII70SF - ARDROL309049A, ROL PWDII70SF - ARDROL309050A, ROL VSTII40SF - ARDROL309051A, ROL VSTII60SF - ARDROL309052A, ROL VSTII40SF - ARDROL309053A, ROL VSTII60SF - ARDROL309054A

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 Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII50SF - ARDPWT309009A, ROL PWDII50SF - ARDPWT309010A, ROL PWDII70SF - ARDPWT309007A, ROL PWDII70SF - ARDPWT309008A, ROL PWDII70SF - ARDPWT309015A, ROL PWDII70SF - ARDPWT309016A, ROL VCS40SF - ARDROL309031A, ROL VCS60SF - ARDROL309032A, ROL VST40SF - ARDROL309033A, ROL VST40SF - ARDROL309034A, ROL VST40SF B - ARDROL309037A, ROL VST60SF - ARDROL309035A, ROL VST60SF - ARDROL309036A, ROL VST60SF B - ARDROL309038A, ROL VCSII40SF - ARDROL309039A, ROL VCSII40SF - ARDROL309040A, ROL VCSII60SF - ARDROL309041A, ROL VCSII60SF - ARDROL309042A, ROL PWDII50SF - ARDROL309043A, ROL PWDII50SF - ARDROL309044A, ROL PWDII70SF - ARDROL309045A, ROL PWDII70SF - ARDROL309046A, ROL PWDII50SF - ARDROL309047A, ROL PWDII50SF - ARDROL309048A, ROL PWDII70SF - ARDROL309049A, ROL PWDII70SF - ARDROL309050A, ROL VSTII40SF - ARDROL309051A, ROL VSTII60SF - ARDROL309052A, ROL VSTII40SF - ARDROL309053A, ROL VSTII60SF - ARDROL309054A. 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-0760-2024.