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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.