Quick Facts at a Glance
- Recall Date
- August 13, 2025
- Hazard Level
- HIGH
- Brand
- CHANGE HEALTHCARE CANADA
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- CHANGE HEALTHCARE CANADA
- Product type
- Radiology Software
- Model numbers
- Version 14.2.2/UDI: (01)17540262030068
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 13, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due to software issue, radiology reports may not be fully displayed when viewing.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact CHANGE HEALTHCARE CANADA COMPANY or your healthcare provider for instructions. Notification method: E-Mail
About This Product
Change Healthcare Radiology Solutions software is used by healthcare providers to generate and view medical imaging reports. This software is critical for ensuring accurate diagnoses based on radiological data.
Why This Is Dangerous
The malfunction in the software results in reports not being fully displayed, which can lead to incomplete medical assessments and potential health risks for patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Healthcare facilities using this software may experience delays in reporting, which can affect patient care and outcomes.
Practical Guidance
How to identify if yours is affected
- Check the software version to confirm it is 14.2.2.
- Verify the model number (01)17540262030068 against your records.
- Assess your usage to ensure you have stopped using the software immediately.
Where to find product info
Serial numbers and model numbers can typically be found in the software's about section or installation documentation.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks after submitting your request.
If the manufacturer is unresponsive
- Document all correspondence attempts.
- Consider reaching out to your healthcare provider for assistance.
- File a complaint with the FDA if necessary.
How to prevent similar issues
- When purchasing software, research for quality assurance certifications.
- Stay informed on software updates and recalls.
- Ensure that technical support is readily accessible for software you use.
Documentation advice
Retain any emails or notifications regarding the recall, and keep records of the software installed.
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Product Details
Software Name: Change Healthcare Radiology Solutions Version: 14.2.2 Model Number: (01)17540262030068 Quantity: 12 programs Distribution: US Nationwide and Canada
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Software issue may cause incomplete report viewing
- Nationwide distribution including AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA
- Stop using the software immediately
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Safety Guide
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