HIGH

Change Healthcare Radiology Software Recalled Over Reporting Issues

Change Healthcare recalled 12 programs of its Radiology Solutions software version 14.2.2 on August 13, 2025. A software issue may prevent radiology reports from displaying fully. Healthcare providers and patients must stop using the software immediately.

Quick Facts at a Glance

Recall Date
August 13, 2025
Hazard Level
HIGH
Brand
CHANGE HEALTHCARE CANADA
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

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

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Product Details

The recall involves Change Healthcare Radiology Solutions software version 14.2.2. It was distributed worldwide, including the US states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA, and in Canada.

The Hazard

The software issue may cause incomplete display of radiology reports. This situation poses significant risks to patient care.

Reported Incidents

No specific incidents or injuries related to this recall have been reported. The software's failure to display complete reports could lead to undiagnosed conditions.

What to Do

Patients and healthcare providers should stop using the software immediately. Follow the instructions provided by Change Healthcare Canada Company.

Contact Information

For more information, contact Change Healthcare Canada Company or your healthcare provider. Visit the FDA recall page for details.

Key Facts

  • 12 programs recalled
  • Affected software version: 14.2.2
  • Distribution in multiple US states and Canada
  • Stop using the software immediately
  • Contact Change Healthcare for instructions

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Version 14.2.2/UDI: (01)17540262030068
Affected States
ALL
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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