Recall Z-0237-2024— CHANGE HEALTHCARE CANADA COMPANY

Name: FDA recall Z-0237-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-12

Class II · Ongoing

Class II FDA medical device recall by CHANGE HEALTHCARE CANADA COMPANY, initiated 2023-10-12. It names one FDA 510(k) clearance: K140909. Product: Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.. Reason: 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..

Recalling firm: CHANGE HEALTHCARE CANADA COMPANY
Classification: Class II
Status: Ongoing
Initiated: 2023-10-12
Firm location: Richmond, Canada

510(k) clearances named in this recall

1 on FDA's record

K140909 — MCKESSON RADIOLOGYMckesson Medical Imaging Company·cleared 2014-07-02

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 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.

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