Z-2071-2025Class II

Change Healthcare Cardiology Hemo Software

Name: Z-2071-2025 Change Healthcare Cardiology Hemo Software
Creator: Change Healthcare Canada Company
Published: 2025-05-22
License: https://open.fda.gov/license/

Change Healthcare Canada Company / initiated 2025-05-22 / Open, Classified / root cause: software

FDA source

CHANGE HEALTHCARE CANADA COMPANY began a recall of Change Healthcare Cardiology Hemo Software on 2025-05-22. FDA classified it as Class II and gives the reason as "Due to complaints, software update may cause software to unexpectedly shutdown". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2071-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-22
Posted: 2025-07-02
Recalling firm: Change Healthcare Canada Company
Product: Change Healthcare Cardiology Hemo Software
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason for recall: Due to complaints, software update may cause software to unexpectedly shutdown.
Root cause tag: software
FDA 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 in commerce: 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 Zealand.
Product codes and lots: Software version 14.3.2/UDI: (01)17540262100051/ 15.0.1/UDI: (01)17540262100105

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2071-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2071-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-07-02
Z-2072-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-07-02

Product code MWI

K131497Class IIMckesson Cardiology HemoMckesson Israel , Ltd. / cleared 2013-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)