15
Apr
2020

Recall – Software error in ECG display

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0

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

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