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Recall Observatory FDA recall evidence

Device product

Change Healthcare Cardiology Hemodynamics Software

Z-2072-2025

May 22, 2025

Class II

Product summary

Firm
CHANGE HEALTHCARE CANADA COMPANY
Event
Event 97046
Status
Ongoing
Classification
Class II
Quantity
4 systems
Official record key
device-enforcement:Z-2072-2025

Official wording

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

Code information: Software version: 15.0.1/UDI: (01)17540262100129

Distribution pattern: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software update may cause