Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management
Summary
The FDA issued a Class II for Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 M by CHANGE HEALTHCARE CANADA COMPANY. Reason: 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 .
Details
Source
Device Recall
External ID
Z-0237-2024
Action Date
2023-11-15
Status
Ongoing
Category
device
Product Description
Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.
Lot/Code Info: UDI/DI 17540262030020
Quantity Affected: 282 units
Reason for Recall
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.
Distribution
US, Canada, Ireland, Saudi Arabia, France, UK
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-12
Company
Richmond
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 171 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-0237-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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