Maquet Rolite OR Light Systems — Class II medical device recall Z-0760-2024
Ongoing recall by Getinge Usa Sales Inc, reported 2024-01-24, distributed nationwide. A potential for a light system to fall in the operating room.
| Recall number | Z-0760-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Usa Sales Inc, Wayne, NJ, United States |
| Recall initiated | 2023-11-08 |
| Classified | 2024-01-18 |
| Reported by FDA | 2024-01-24 |
| Distributed | Nationwide (US) |
| Quantity | 236,793 units |
| UPC / GTIN / UDI-DI | 03700712411978, 03700712411985, 03700712412036, 03700712412043, 03700712412050, 03700712412067, 03700712412111, 03700712412128, 03700712417062, 03700712417079, 03700712417086, 03700712417093, 03700712417109, 03700712417116, 03700712419240, 03700712419257, 03700712422707, 03700712422714, 03700712422721, 03700712422738, 03700712422745, 03700712422752, 03700712422769, 03700712422776, 03700712422783 and 7 more |
| Model numbers | ARDPWT309001A, ARDPWT309002A, ARDPWT309007A, ARDPWT309008A, ARDPWT309009A, ARDPWT309010A, ARDPWT309015A, ARDPWT309016A, ARDROL309031A, ARDROL309032A, ARDROL309033A, ARDROL309034A, ARDROL309035A, ARDROL309036A, ARDROL309037A, ARDROL309038A, ARDROL309039A, ARDROL309040A, ARDROL309041A, ARDROL309042A, ARDROL309043A, ARDROL309044A, ARDROL309045A, ARDROL309046A, ARDROL309047A and 19 more |
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
Reason for recall
A potential for a light system to fall in the operating room.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0760-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.