Recall Z-1937-2018— Maquet SAS
Class II · Terminated
Class II FDA medical device recall by Maquet SAS, initiated 2018-04-19, terminated 2020-11-18. It names one FDA 510(k) clearance: K130513. Product: 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.. Reason: Potential keypad failure on VOLISTA StandOP Surgical Lights..
- Recalling firm
- Maquet SAS
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-19
- Terminated
- 2020-11-18
- Firm location
- Orleans, N/A, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Potential keypad failure on VOLISTA StandOP Surgical Lights.
Data sourced from openFDA. This site is unofficial and independent of the FDA.