Recall Z-1508-2021— CHANGE HEALTHCARE CANADA COMPANY

Name: FDA recall Z-1508-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-17

Class II · Ongoing

Class II FDA medical device recall by CHANGE HEALTHCARE CANADA COMPANY, initiated 2021-03-17. It names one FDA 510(k) clearance: K181185. Product: Change Healthcare Enterprise Viewer. Reason: Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display..

Recalling firm: CHANGE HEALTHCARE CANADA COMPANY
Classification: Class II
Status: Ongoing
Initiated: 2021-03-17
Firm location: Richmond, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K181185 — Change Healthcare Enterprise ViewerChange Healthcare Canada Company·cleared 2018-08-29

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 Enterprise Viewer

Reason for recall

Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.

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