Change Healthcare Cardiology Hemodynamics Software
- Company
- Change Healthcare Canada Company
- Recall Initiated
- May 22, 2025
- Posted
- July 2, 2025
- Recall Number
- Z-2072-2025
- Quantity
- 4 systems
- Firm Location
- Richmond Canada
Reason for Recall
Due to complaints, software update may cause software to unexpectedly shutdown.
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.
Lot / Code Info
Software version: 15.0.1/UDI: (01)17540262100129
Root Cause
Software design
Action Taken
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.