UNIQ 1 — Class II medical device recall Z-2670-2016
Terminated recall by Philips Electronics North America Corporation, reported 2016-09-07, distributed nationwide. Increase in the failure rate of certain low-voltage DC power supplies (DCPS)
| Recall number | Z-2670-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2016-07-07 |
| Classified | 2016-08-26 |
| Reported by FDA | 2016-09-07 |
| Terminated | 2020-07-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GR, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KE, KR, LB, LK, LT, MA, MT, MX, MY, NL, NO, NP, OM, PE, PH, PK, PL, PT, QA, RO, SA, SE, SG, SK, TH, TN, TR, TW, UA, UY, VN, ZA |
| Quantity | 1,536 devices |
Product
UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10 biplane, 722029; UNIQ FD10 OR Table, 722033; UNIQ FD10/10 OR Table, 722034; UNIQ FD20 OR Table, 722035; UNIQ FD20/20, 722038; UNIQ FD20/20 biplane OR Table, 722039; UNIQ FD20/15, 722058; UNIQ FD20/15 OR Table 722059
Reason for recall
Increase in the failure rate of certain low-voltage DC power supplies (DCPS)
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-2670-2016. 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.