Data Foundry

Medical device recalls 2016

Allura Xper with release R8 — Class II medical device recall Z-2669-2016

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 numberZ-2669-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPhilips Electronics North America Corporation, Andover, MA, United States
Recall initiated2016-07-07
Classified2016-08-26
Reported by FDA2016-09-07
Terminated2020-07-14
DistributedNationwide (US)
Countries outside the USAE, 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
Quantity1,536 devices

Product

Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allura Xper FD20/10 biplane, 722029; Allura Xper FD10 OR Table, 722033; Allura Xper FD10/10 OR Table, 722034; Allura Xper FD20 OR Table, 722035; Allure Xper FD20/20 , 722038; Allura Xper FD20/20 biplane OR Table, 722039; Allura Xper FD20/15, 722058; Allura Xper 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-2669-2016. 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.