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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

CHANGE HEALTHCARE CANADA COMPANY: Radiology Solutions Software Recalled for Failing to Update Medical Records

Agency Publication Date: November 6, 2023
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Summary

Change Healthcare has recalled 282 units of its Radiology Solutions software, specifically versions 14.0, 14.1, and 14.2. This medical image and information management software has a defect where it may fail to update patient records in external applications. This means that important medical data may not be synchronized correctly across different healthcare systems. Consumers should contact their healthcare provider or the manufacturer to ensure their software is updated and their records are accurate.

Risk

The software failure to update external records can lead to inconsistent or missing patient information across different medical platforms. This poses a risk of incorrect diagnosis or delayed treatment because healthcare providers may be making decisions based on outdated or incomplete medical data.

What You Should Do

  1. Identify if your facility is using Change Healthcare Radiology Solutions software versions 14.0, 14.1, or 14.2.
  2. Check the software identification information for UDI/DI 17540262030020 or Recall Number Z-0237-2024 to confirm the affected product.
  3. Contact Change Healthcare directly or your facility's IT/Radiology department to confirm if the necessary software updates or patches have been applied to resolve the communication issue with external applications.
  4. Contact your healthcare provider or Change Healthcare for further instructions regarding system status and any potential impacts on patient records.
  5. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer-initiated software correction

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Change Healthcare Radiology Solutions, software version 14.0
Model / REF:
UDI/DI 17540262030020
Lot Numbers:
Recall #: Z-0237-2024
Product: Change Healthcare Radiology Solutions, software version 14.1
Model / REF:
UDI/DI 17540262030020
Lot Numbers:
Recall #: Z-0237-2024
Product: Change Healthcare Radiology Solutions, software version 14.2
Model / REF:
UDI/DI 17540262030020
Lot Numbers:
Recall #: Z-0237-2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93259
Status: Active
Manufacturer: CHANGE HEALTHCARE CANADA COMPANY
Sold By: Change Healthcare Canada Company
Manufactured In: Canada
Units Affected: 282 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.