VOLISTA StandOP Surgical Light — Class II medical device recall Z-1349-2018
Terminated recall by GETINGE US SALES LLC, reported 2018-04-18, distributed nationwide. The manufacturer received complaints indicating that the device's central handle holder detaches easily from t
| Recall number | Z-1349-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GETINGE US SALES LLC, Wayne, NJ, United States |
| Recall initiated | 2018-02-07 |
| Classified | 2018-04-10 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2021-09-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GH, HK, HR, HU, IN, IQ, IR, IT, JO, JP, KE, KR, LB, LU, LV, MX, MY, NG, NL, OM, PA, PK, PL, PT, PY, RO, RS, SA, SE, SG, SI, SK, TH, TR, TT, TW, ZA |
| Quantity | 5,214 |
| Reason classes | sterility, device malfunction |
| Serial numbers | 20502, 20503, 21001, 21002, 22000, 25002, 25005, 25006, 25007, 28003, 28004, 31000, 31001, 31002, 31003, 31004, 31005, 31006, 31008, 31009, 31010, 31011, 31012, 31013, 31014 and 86 more |
| Model numbers | ARD568811901, ARD568811911, ARD568811951, ARD568811961, VLT600DF, VLT600SF |
Product
VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These surgical lights may be installed in surgical suites, examining rooms, doctors' surgeries and outpatient consultations.
Reason for recall
The manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical use. In the event of such detachment, particles from the handle holder ring could fall into the sterile field during a procedure.
Machine access
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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.