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U.S. Department of Health and Human Services

Class 2 Device Recall Change Healthcare

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  Class 2 Device Recall Change Healthcare see related information
Date Initiated by Firm October 12, 2023
Date Posted November 06, 2023
Recall Status1 Open3, Classified
Recall Number Z-0237-2024
Recall Event ID 93259
510(K)Number K140909  
Product Classification System, image processing, radiological - Product Code LLZ
Product Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2
Medical image and information management software.
Code Information UDI/DI 17540262030020
Recalling Firm/
Manufacturer		 CHANGE HEALTHCARE CANADA COMPANY
10711 Cambie Rd Suite 130
Richmond Canada
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action Field Safety Notice was distributed to all consignees on10/12/2023 by email. The notice explained the issue, potential risk to the patient, and directed users to to check the CHRS Exception Tracker on a regular basis, as failed updates will be listed with details on the failure. Recommended actions to take on potentially affected data: Impacted data can be identified by using the CHRS Exception Tracker. Customers are advised to review records of recent updates from CHRS to external systems and manually update any changes to study records that may have been missed. Change Healthcare will install a software update.
Quantity in Commerce 282 units
Distribution US, Canada, Ireland, Saudi Arabia, France, UK
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LLZ and Original Applicant = MCKESSON MEDICAL IMAGING COMPANY
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