Change Healthcare Cardiology Hemo Software
FDA device recall Z-2071-2025 · posted 2025-07-02 · Open, Classified
Recall details
- Recalling firm
- CHANGE HEALTHCARE CANADA COMPANY
- Reason for recall
- Due to complaints, software update may cause software to unexpectedly shutdown.
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- MWI
- Quantity affected
- 29 systems
- 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 Zeala
- Date initiated
- 2025-05-22
- Date posted
- 2025-07-02
- Location
- Richmond, Canada
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MCKESSON CARDIOLOGY HEMO (K131497) | Mckesson Israel , Ltd. | 2013-12-05 |