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
StatusOngoing
ReasonDue to software issue, radiology reports may not be fully displayed when viewing.
ProductChange Healthcare Radiology Solutions software version 14.2.2
Quantity12 programs
DistributionWorldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.
Initiated2025-08-13
Classified2025-10-02
Recall numberZ-0030-2026
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-0030-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97545/

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