Change Healthcare Radiology Solutions recallZ-0237-2024 · Change Healthcare Canada Company · initiated Oct 12, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Change Healthcare Canada Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0237-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 12, 2023
- Posted by the FDA
- Nov 6, 2023
- Recalling firm
- Change Healthcare Canada Company
- Quantity
- 282 units
- Product code
- LLZ
- FDA submissions
- K140909
- Distribution
- US, Canada, Ireland, Saudi Arabia, France, UK
Product description
Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.
Code information (models, lots, serial numbers)
UDI/DI 17540262030020
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Change Healthcare Radiology Solutions 14.0Change Healthcare Canada Company · System, Image Processing, Radiological2 recalls1 report
Product lines
Other devices under the same FDA submission
1 device cleared under K140909 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Change Healthcare Radiology Solutions 14.2.2Change Healthcare Canada Company · System, Image Processing, Radiological1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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