Change Healthcare Cardiology Software (Change Healthcare) – Unexpected Shutdown (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Change Healthcare Cardiology Hemo Software
Brand
CHANGE HEALTHCARE CANADA COMPANY
Lot Codes / Batch Numbers
Software version 14.3.2/UDI: (01)17540262100051/ 15.0.1/UDI: (01)17540262100105
Products Sold
Software version 14.3.2/UDI: (01)17540262100051/ 15.0.1/UDI: (01)17540262100105
CHANGE HEALTHCARE CANADA COMPANY is recalling Change Healthcare Cardiology Hemo Software due to Due to complaints, software update may cause software to unexpectedly shutdown.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to complaints, software update may cause software to unexpectedly shutdown.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026