VOLISTA StandOP — Class II medical device recall Z-1937-2018
Terminated recall by Maquet SAS, reported 2018-06-06, distributed nationwide. Potential keypad failure on VOLISTA StandOP Surgical Lights.
| Recall number | Z-1937-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet SAS, Orleans, N/A, France |
| Recall initiated | 2018-04-19 |
| Classified | 2018-05-25 |
| Reported by FDA | 2018-06-06 |
| Terminated | 2020-11-18 |
| Distributed | Nationwide (US) |
| Quantity | 187 |
| Serial numbers | 20502, 20503, 21001, 21002, 25002, 25004, 25005, 25006, 25007, 28003, 28004, 31000, 31001, 31002, 31003, 31004, 31005, 31006, 31008, 31009, 31010, 31011, 31012, 31013, 31014 and 150 more |
| Model numbers | 568811901, 600, ARD568801560, VLT600SFAIM |
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 for recall
Potential keypad failure on VOLISTA StandOP Surgical Lights.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1937-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.