Change Healthcare Cardiology Hemo Software
FDA Recall Z-2071-2025 · Posted 2025-07-02
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Recalling FirmCHANGE HEALTHCARE CANADA COMPANY
Recall StatusOpen, Classified
Product CodeMWI
Date Initiated2025-05-22
Product Quantity29 systems
Reason for Recall
Due to complaints, software update may cause software to unexpectedly shutdown.
Firm Action
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.
Root Cause
Software design
Distribution Pattern
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.
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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