VOLISTA StandOP Surgical Light — Class II medical device recall Z-1308-2022
Ongoing recall by Getinge Usa Sales Inc, reported 2022-07-06, distributed nationwide. Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irrit
| Recall number | Z-1308-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Usa Sales Inc, Wayne, NJ, United States |
| Recall initiated | 2022-05-06 |
| Classified | 2022-06-30 |
| Reported by FDA | 2022-07-06 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 03700712400866, 03700712400873, 03700712400903, 03700712401559, 03700712401566, 03700712401597, 03700712401603, 03700712401719, 03700712401726, 03700712401757, 03700712401764 |
| Serial numbers | 00001, 00002, 00003, 00004, 00005, 00006, 00007, 00008, 00100, 00101, 00108, 00109, 00110, 00113, 00114, 00115, 00116, 00117, 00118, 00119, 00125, 00126, 20502, 20503, 25004 and 239 more |
| Model numbers | ARD568811901, ARD568811911, ARD568811961, ARDVST229000A, ARDVST229001A, ARDVST229002A, ARDVST229003A, ARDVST229034A, ARDVST229036A, ARDVST229037A, VLT600DFAIM, VLT600SFAIM, VST60DFAIM, VST60SF, VST60SFAIM, VST66DF, VST66DFAIM, VST66SF, VST66SFAIM |
Product
VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM ARDVST229002A VST66SF AIM ARDVST229003A VST66DF AIM ARDVST229034A VST60SF ARDVST229036A VST66SF ARDVST229037A VST66DF
Reason for recall
Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the patient body or in the operating field.
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-1308-2022. 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.