Change Healthcare Cardiology Hemo recallZ-2072-2025 · Change Healthcare Canada Company · initiated May 22, 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 complaints, software update may cause software to unexpectedly shutdown.
FDA root cause category: Software design
What the company is doing
On May 22, 2025, Change Healthcare issued a "Urgent Field Safety notice" to affected consignees via e-mail. On May June 11, 2025, Change Healthcare sent out an updated notification providing additional information. Change Healthcare asked consignees to take the following actions: 1. Change Healthcare has developed a software update that addresses this issue. Contact Change Healthcare support to schedule its deployment. 2. This notice must be distributed to all personnel within your organization who need to be aware of this notice. Customers should alert other affiliated parties that may be affected by this notice. 3. please maintain awareness of this Urgent Field Safety Notice until the issue has been fully resolved. 4. Please notify our Customer Support department that you have read and understood this field safety notice.
Recall details
- Recall number
- Z-2072-2025
- Status
- Open, Classified
- Initiated by the company
- May 22, 2025
- Posted by the FDA
- Jul 2, 2025
- Recalling firm
- Change Healthcare Canada Company
- Quantity
- 4 systems
- Product code
- MWI
- FDA submissions
- K230881
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, KY MO, MS, NE, NH, NJ, PA, TN, TX, WA and the countries of Australia, Canada, Germany, Great Britain, Ireland, Israel, New Zealand.
Product description
Change Healthcare Cardiology Hemodynamics Software
Code information (models, lots, serial numbers)
Software version: 15.0.1/UDI: (01)17540262100129
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Change Healthcare Cardiology Hemo 15.1Change Healthcare Canada Company · Computer, Diagnostic, Programmable4 recalls1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 97046).
- Z-2071-2025 · Open, ClassifiedChange Healthcare Cardiology Hemo Software
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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