Change Healthcare Cardiology Hemo recallZ-0959-2025 · A L I Technologies Ltd · initiated Dec 2, 2024
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 A L I Technologies Ltd 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
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
FDA root cause category: Software design
What the company is doing
On December 2, 2024 Change Healthcare Canada Company issued a "Urgent Field Safety" Recall Notice to affected consignees. Change Healthcare Canada Company ask consignees to take the following actions: 1. Please contact and work with our Customer Support team to identify and correct any potentially affected data. 2. This notice must be distributed to all personnel within your organization who need to be aware of this Urgent Field Safety Notice. Customers should alert other affiliated parties that may be affected by this Urgent Field Safety Notice. 3. To ensure effectiveness of any required corrective actions, 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, and if you want the product update to be installed on your system. Customer Support number by region: US / Canada: 1 877 654 4366 5. Once again, until the product update is installed at your site, Change Healthcare recommends that the immediate actions (described above) be taken.
Recall details
- Recall number
- Z-0959-2025
- Status
- Open, Classified
- Initiated by the company
- Dec 2, 2024
- Posted by the FDA
- Jan 16, 2025
- Recalling firm
- A L I Technologies Ltd
- Quantity
- 2 units
- Product code
- MWI
- FDA submissions
- K230881
- Distribution
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PA, SC, SD, TN, TX, WA, WI and the countries of Australia, Israel, Canada, Germany, Ireland, United Kingdom.
Product description
Change Healthcare Cardiology Hemodynamics software
Code information (models, lots, serial numbers)
Software version 15.01/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 96025).
- Z-0957-2025 · Open, ClassifiedMcKesson Cardiology Hemo software
- Z-0958-2025 · 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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