Recall Z-0072-2021— CHANGE HEALTHCARE CANADA COMPANY

Name: FDA recall Z-0072-2021
Creator: U.S. Food and Drug Administration
Published: 2020-08-25

Class II · Terminated

Class II FDA medical device recall by CHANGE HEALTHCARE CANADA COMPANY, initiated 2020-08-25, terminated 2021-02-16. It names one FDA 510(k) clearance: K140909. Product: Change Healthcare Radiology Solutions 14.0. Reason: Software defect which may potentially result in one or more images missing in a study.

Recalling firm: CHANGE HEALTHCARE CANADA COMPANY
Classification: Class II
Status: Terminated
Initiated: 2020-08-25
Terminated: 2021-02-16
Firm location: Richmond, N/A, 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 14.0

Reason for recall

Software defect which may potentially result in one or more images missing in a study

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