Recall archive / FDA device enforcement
Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDP... — FDA record Z-0760-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 8, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- A potential for a light system to fall in the operating room.
- Classification
- Class II
- Recalling firm
- Getinge Usa Sales Inc
- Quantity
- 236793 units in total
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0760-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide. Global Distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 24, 2024
- Recall initiation date
- Nov 8, 2023
- Center classification date
- Jan 18, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.