FDA recall Z-2072-2025

CHANGE HEALTHCARE CANADA COMPANY · Class II · device

Product

Change Healthcare Cardiology Hemodynamics Software

Reason for recall

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

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.

Key facts

Status: Ongoing
Initiation date: 2025-05-22
Report date: 2025-07-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Richmond, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2072-2025