Data Foundry

Medical device recalls 2021

Philips Allura Xper System: Interventional Fluoroscopic X-Ray System… — Class II medical device recall Z-1904-2021

Terminated recall by Philips Medical Systems Nederlands, reported 2021-06-30, distributed in AL, AZ, FL, GA, IL, MA, MO, NJ…. Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability

Recall numberZ-1904-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPhilips Medical Systems Nederlands, Best, N/A, Netherlands
Recall initiated2016-06-23
Classified2021-06-21
Reported by FDA2021-06-30
Terminated2023-02-08
DistributedAL, AZ, FL, GA, IL, MA, MO, NJ, OR, VA
Countries outside the USAE, BR, CN, CO, CZ, ES, FR, GB, IN, JP, MX, NL, OM, PL, SG
Quantity42 devices

Product

Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.

Reason for recall

Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering.

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-1904-2021. 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.