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U.S. Department of Health and Human Services

Class 2 Device Recall Change Healthcare Radiology Solutions Software

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 Class 2 Device Recall Change Healthcare Radiology Solutions Softwaresee related information
Date Initiated by FirmAugust 13, 2025
Date PostedOctober 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0030-2026
Recall Event ID 97545
510(K)NumberK140909 
Product Classification System, image processing, radiological - Product Code LLZ
ProductChange Healthcare Radiology Solutions software version 14.2.2
Code Information Version 14.2.2/UDI: (01)17540262030068
FEI Number 3003757840
Recalling Firm/
Manufacturer		 CHANGE HEALTHCARE CANADA COMPANY
10711 Cambie Rd Suite 130
Richmond Canada
Manufacturer Reason
for Recall		Due to software issue, radiology reports may not be fully displayed when viewing.
FDA Determined
Cause 2		Software Design Change
ActionOn August 13, 2025, Change Healthcare Canada Company issued a Urgent Medical Device Recall notification to affected consignees via Email. Chang Healthcare asked consignees to take the following actions: 1. Generate an audit report to list all studies accessed since CHRS 14.2.2 client was first installed. 2. Re-evaluate the identified cases and take any necessary follow-up measures to confirm that each patient s diagnosis and management remain appropriate. 4. This notice must be distributed to all personnel within your organization who need to be aware 5. To ensure effectiveness of any required corrective actions, please maintain awareness of this RECALL until the issue has been fully resolved. 6. Please notify our Customer Support department at: 1-800-663-2533 that you have read and understood the recall notice and schedule your product update to be installed on your system.
Quantity in Commerce12 programs
DistributionWorldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LLZ
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