Recall Z-2071-2025— CHANGE HEALTHCARE CANADA COMPANY

Name: FDA recall Z-2071-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-22

Class II · Ongoing

Class II FDA medical device recall by CHANGE HEALTHCARE CANADA COMPANY, initiated 2025-05-22. It names one FDA 510(k) clearance: K131497. Product: Change Healthcare Cardiology Hemo Software. Reason: Due to complaints, software update may cause software to unexpectedly shutdown..

Recalling firm: CHANGE HEALTHCARE CANADA COMPANY
Classification: Class II
Status: Ongoing
Initiated: 2025-05-22
Firm location: Richmond, Canada

510(k) clearances named in this recall

1 on FDA's record

K131497 — MCKESSON CARDIOLOGY HEMOMckesson Israel , Ltd.·cleared 2013-12-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Change Healthcare Cardiology Hemo Software

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.