FDA recall Z-0237-2024

Product

Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.

Reason for recall

Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external applications.

Distribution

US, Canada, Ireland, Saudi Arabia, France, UK

Key facts

Status

Ongoing

Initiation date

2023-10-12

Report date

2023-11-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Richmond, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0237-2024