Change Healthcare Cardiology Hemodynamics software
FDA Recall Z-0959-2025 · Posted 2025-01-16
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Recalling FirmA L I Technologies Ltd
Recall StatusOpen, Classified
Product CodeMWI
Date Initiated2024-12-02
Product Quantity2 units
Reason for Recall
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Firm Action
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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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