Data Foundry

Medical device recalls 2021

Change Healthcare Enterprise Viewer — Class II medical device recall Z-1508-2021

Ongoing recall by CHANGE HEALTHCARE CANADA COMPANY, reported 2021-05-05, distributed in AK, AZ, CA, FL, HI, IA, IL, IN…. Change Healthcare has identified an intermittent software defect which may result in an anchor study failing t

Recall numberZ-1508-2021
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCHANGE HEALTHCARE CANADA COMPANY, Richmond, N/A, Canada
Recall initiated2021-03-17
Classified2021-04-28
Reported by FDA2021-05-05
DistributedAK, AZ, CA, FL, HI, IA, IL, IN, KY, MI, NE, NY, OH, PA, TX, WA, WI, WY
Quantity28 units
Reason classessoftware

Product

Change Healthcare Enterprise Viewer

Reason for recall

Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.

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-1508-2021. 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.