Orleans, N/A, France
Maquet SAS recalls
3 recalls recorded since 2018, most recently on 7 August 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 7 August 2026
- Reason
- The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3224-2026
- PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;
Terminated Class II Medical devices
- Recall started
- 14 June 2018
- Terminated
- 23 June 2022
- Reason
- 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.
- Distribution
- Worldwide Distribution - US Nationwide in the states of AR, AZ, CA, CO, CT, FL, GA, IA, ID, KS, KY, LA, MD, ME, MO, NE, NY, OH, OR, TN, TX, UT, and WA. Foreign distribution to Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil Cameroon, Canada, Chile, China, Colombia, Croatia, Czech
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2502-2018
- 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 VL
Terminated Class II Medical devices
- Recall started
- 19 April 2018
- Terminated
- 18 November 2020
- Reason
- Potential keypad failure on VOLISTA StandOP Surgical Lights.
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: (AE, AR, AT, AU, BD, BE, BO, BR, CA, CH, CL, CM, CN, CO, CZ, DE, DK, EC, EE, EG, ES, Fl, FR, GB, GH, HK, HR, HU, IE, IN, IQ, IR, IT, JO, JP, KE, KR, LB, LU, LV, MQ, MX, MY, NA, NG, NL, OM, PA, PK, PL, PT, PY, RO, RS, SA, SE, SG, SI, SK, TH,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1937-2018
- 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, VLT60
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.