Recall – Software error in ECG display

Company: Change Healthcare Canada Company
Date of Enforcement Report: 4/15/2020
Class II

PRODUCT

McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

  • Recall Number: Z-1682-2020

REASON

Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format.

RECALLING FIRM/MANUFACTURER

Change Healthcare Canada Company on 2/10/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

51 units

DISTRIBUTION

US Nationwide and International

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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