FDA recall Z-0030-2026

CHANGE HEALTHCARE CANADA COMPANY · Class II · device

Product

Change Healthcare Radiology Solutions software version 14.2.2

Reason for recall

Due to software issue, radiology reports may not be fully displayed when viewing.

Distribution

Worldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.

Key facts

Status
Ongoing
Initiation date
2025-08-13
Report date
2025-10-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Richmond, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0030-2026