FDA Recall Open, Classified

Change Healthcare Cardiology Hemodynamics Software

Recall: Z-2072-2025 · Initiated May 22, 2025

Recall

Recall Number
Z-2072-2025
Event Number
97046
Firm
CHANGE HEALTHCARE CANADA COMPANY
FEI Number
3003757840
Product Code
MWI
Status
Open, Classified
Root Cause
Software design
Initiated
May 22, 2025
Posted
July 2, 2025
Address
10711 Cambie Rd, Suite 130, Richmond Canada

Description

Change Healthcare Cardiology Hemodynamics Software

Reason

Due to complaints, software update may cause software to unexpectedly shutdown.

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.

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.

Quantity

4 systems