Change Healthcare Radiology Solutions recallZ-0030-2026 · Change Healthcare Canada Company · initiated Aug 13, 2025
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
Due to software issue, radiology reports may not be fully displayed when viewing.
FDA root cause category: Software Design Change
What the company is doing
On 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.
Recall details
- Recall number
- Z-0030-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 13, 2025
- Posted by the FDA
- Oct 2, 2025
- Recalling firm
- Change Healthcare Canada Company
- Quantity
- 12 programs
- Product code
- LLZ
- FDA submissions
- K140909
- Distribution
- Worldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.
Product description
Change Healthcare Radiology Solutions software version 14.2.2
Code information (models, lots, serial numbers)
Version 14.2.2/UDI: (01)17540262030068
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 14.2.2Change Healthcare Canada Company · System, Image Processing, Radiological1 recall0 reports
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 14.0Change Healthcare Canada Company · System, Image Processing, Radiological2 recalls1 report
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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