RegWardenFDA facility compliance records
Recall

Class II — CHANGE HEALTHCARE CANADA COMPANY

Recalling firmChange Healthcare Canada Company
Registered facilityCHANGE HEALTHCARE CANADA COMPANY (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonSoftware defect which may potentially result in one or more images missing in a study
ProductChange Healthcare Radiology Solutions 14.0
Quantity5 devices
DistributionDomestic distribution to VT, MS, WV, NE
Initiated2020-08-25
Classified2020-10-08
Terminated2021-02-16
Recall numberZ-0072-2021
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — CHANGE HEALTHCARE CANADA COMPANY (Z-0072-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86401/

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