Maquet SAS
FDA adverse event reports naming Maquet SAS as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MAQUET SAS.
- Total reports
- 4,500
- Deaths
- 0
- Injuries
- 82
- Malfunctions
- 4,410
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Light, Surgical, Ceiling MountedFSY3,256
- Lamp, SurgicalFTD794
- Device, Medical Examination, Ac PoweredKZF221
- Holder, Camera, SurgicalFXR121
- Light, Surgical, Floor StandingFSS44
- Tubing, Pressure And AccessoriesBYX41
- Light, Surgical, AccessoriesFTA14
- Graft, Vascular, Synthetic/Biologic CompositeMAL4
- Camera, Surgical And AccessoriesKQM3
- Prosthesis, Vascular Graft, Of 6mm And Greater DiameterDSY1
Recent recalls
- TerminatedDevice Design
VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF AIM STP QL; 568821960, VLT600DF STP QL; 568821961, VLT600DF AIM STP QL VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or patient during surgical operations, diagnostics and treatment.
Potential keypad failure on VOLISTA StandOP Surgical Lights.
- TerminatedProcess control
VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF AIM STP QL; ARD568821910 VLT600SF STP QL; ARD568811901 VLT600SF AIM STP Product Usage: The Maquet VOLISTA surgical lights are designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. StandOP VOLISTA is a system of ceiling-mounted surgical lights suited for installation in surgical suites, examining rooms, doctors surgeries and out-patient consultations.
Certain VOLISTA StandOP Surgical Lights have been identified as having a potential light head detachment issue. Improper assembly of the bracket that connects the light head to the axle fork could result in the light head bracket breaking, causing the light head to detach from the arm and become suspended only from the cabling inside the arm. Use of an affected device may result in serious injury to patient and/or medical staff if the light head detaches and drops, impacting patient and/or medical staff during demonstration, service, or use.
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