Maquet SAS Recalls
2 recalls on record · June 6, 2018 to July 25, 2018 · Medical Devices
July 25, 2018Medical DevicesFDA
Maquet SAS recalls VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT
Hazard: 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.
June 6, 2018Medical DevicesFDA
Maquet SAS recalls VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. AR
Hazard: Potential keypad failure on VOLISTA StandOP Surgical Lights.