FDA Medical Device Recalls (openFDA)
CHANGE HEALTHCARE CANADA COMPANY: Change Healthcare Cardiology Hemodynamics Software
- Recall number
- Z-2072-2025
- Recalling firm
- CHANGE HEALTHCARE CANADA COMPANY
- Product
- Change Healthcare Cardiology Hemodynamics Software
- Status
- Open, Classified
- Initiated
- 2025-05-22
- Posted
- 2025-07-02
- Terminated
- not on file
- Reason
- Due to complaints, software update may cause software to unexpectedly shutdown.
- Root cause
- Software design
- 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.
- Quantity
- 4 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 Zealand.
- Lot, serial or model codes
- Software version: 15.0.1/UDI: (01)17540262100129
- 510(k) numbers
- ["K230881"]
- PMA numbers
- not on file
- Product code
- MWI
- Firm FEI
- 3003757840
- Firm city
- Richmond
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28