The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical… — Class II medical device recall Z-1990-2015
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2015-07-15, distributed nationwide. Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of th
| Recall number | Z-1990-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2015-05-29 |
| Classified | 2015-07-07 |
| Reported by FDA | 2015-07-15 |
| Terminated | 2017-04-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IQ, JO, JP, KE, KW, LK, LU, MX, MY, NG, NL, NO, OM, PA, PE, PH, PK, PL, PT, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TT, TW, UY, VE, ZA |
| Quantity | 646 units |
| Serial numbers | 10000, 10001, 10002, 10011, 10012, 10021, 10022, 10023, 10027, 12026, 12054, 12067, 12102, 12150, 12178, 12179, 12194, 12196, 12198, 12254, 12295, 12353, 12386, 12646, 12648 and 19 more |
| Model numbers | 567910904, 567910906, 567910913, 567910915, 567910917, 567910918, 567910923, 567910936, 567910938, 567910957, 567910958, 567910961, 567910964, 567910965, 567910968, 567910970, 567910971, 567910986, 567910990, 567910993, 567912907, 567912908, 567912909, 567912911, 567912912 and 2 more |
Product
The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis.
Reason for recall
Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall into the surgical field, when the suspension arms are mounted above the surgical table.
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-1990-2015. 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.