Change Healthcare Radiology Solutions software version 14.2.2
Summary
The FDA issued a Class II for Change Healthcare Radiology Solutions software version 14.2.2 by CHANGE HEALTHCARE CANADA COMPANY. Reason: Due to software issue, radiology reports may not be fully displayed when viewing..
Details
Source
Device Recall
External ID
Z-0030-2026
Action Date
2025-10-08
Status
Ongoing
Category
device
Product Description
Change Healthcare Radiology Solutions software version 14.2.2
Lot/Code Info: Version 14.2.2/UDI: (01)17540262030068
Quantity Affected: 12 programs
Reason for Recall
Due to software issue, radiology reports may not be fully displayed when viewing.
Distribution
Worldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-13
Company
Richmond, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.
CHANGE HEALTHCARE CANADA COMPANY has 10 FDA actions in our database, including 8 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CHANGE HEALTHCARE CANADA COMPANY) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CHANGE HEALTHCARE CANADA COMPANY have FDA actions?
CHANGE HEALTHCARE CANADA COMPANY has 10 FDA actions in our database, including 8 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0030-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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