Recall – Enterprise viewer fails intermittently

Company: Change Healthcare Canada Company
Date of Enforcement Report: 5/5/2021
Class II

PRODUCT

Change Healthcare Enterprise Viewer

Recall Number: Z-1508-2021

REASON

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

RECALLING FIRM/MANUFACTURER

Change Healthcare Canada Company on 3/17/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

28 units

DISTRIBUTION

U.S. Nationwide

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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