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Open, Classified

Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.

FDA Recall Z-0237-2024 · Posted 2023-11-06

Recalling FirmCHANGE HEALTHCARE CANADA COMPANY
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2023-10-12
Product Quantity282 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.

Firm 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.

Root Cause

Software design

Distribution Pattern

US, Canada, Ireland, Saudi Arabia, France, UK

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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