Data Foundry

Medical device recalls 2025

Change Healthcare Radiology Solutions software version 14 — Class II medical device recall Z-0030-2026

Ongoing recall by CHANGE HEALTHCARE CANADA COMPANY, reported 2025-10-08, distributed nationwide. Due to software issue, radiology reports may not be fully displayed when viewing.

Recall numberZ-0030-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCHANGE HEALTHCARE CANADA COMPANY, Richmond, N/A, Canada
Recall initiated2025-08-13
Classified2025-10-02
Reported by FDA2025-10-08
DistributedNationwide (US)
Countries outside the USCA
Quantity12 programs
Reason classessoftware
UPC / GTIN / UDI-DI17540262030068

Product

Change Healthcare Radiology Solutions software version 14.2.2

Reason for recall

Due to software issue, radiology reports may not be fully displayed when viewing.

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-0030-2026. 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.