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