RegWardenFDA facility compliance records
Company

Change Healthcare Canada Company

9 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2020: 2 recalls; 2021: 2 recalls; 2023: 2 recalls; 2024: 1 recalls; 2025: 2 recalls201720182019220202202120222202312024220252026
  • Recalls (9)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2025-08-13
    Due to software issue, radiology reports may not be fully displayed when viewing.
  • Class IIOngoing2025-05-22
    Due to complaints, software update may cause software to unexpectedly shutdown.
  • Class IIOngoing2024-08-21
    A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemog…
  • Class IIOngoing2023-11-01
    Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
  • Class IIOngoing2023-10-12
    Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external applications.
  • Class IIOngoing2021-04-19
    A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
  • Class IIOngoing2021-03-17
    Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.
  • Class IITerminated2020-08-25
    Software defect which may potentially result in one or more images missing in a study
  • Class IIOngoing2020-02-10
    Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Change Healthcare Canada Company — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-8022257-change-healthcare-canada-company/

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