Device product
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
Z-0760-2024
Product summary
- Event
- Event 93567
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 236793 units in total
- Official record key
device-enforcement:Z-0760-2024
Official wording
Reason: A potential for a light system to fall in the operating room.
Code information: All systems affected UDI-DI: 3700712411978 3700712411985 3700712412050 3700712412067 3700712412036 3700712412043 3700712412111 3700712412128 3700712417062 3700712417079 3700712417086 3700712417093 3700712419240 3700712417109 3700712417116 3700712419257 3700712422707 3700712422714 3700712422721 3700712422738 3700712422745 3700712422752 3700712422769 3700712422776 3700712422783 3700712422790 3700712422806 3700712422813 3700712422820 3700712422837 3700712422844 3700712422851
Distribution pattern: US Nationwide. Global Distribution.
Derived failure modes
-
Unknown
A potential for a light system to fall in the operating room.