PlainRecalls
FDA Devices Moderate Class II Ongoing

McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

Reported: April 15, 2020 Initiated: February 10, 2020 #Z-1682-2020

Product Description

McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

Reason for Recall

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

Details

Units Affected
51 units
Distribution
Distribution US nationwide, Canada and the United Kingdom
Location
Richmond, British Columbia

Frequently Asked Questions

What product was recalled?
McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management. Recalled by CHANGE HEALTHCARE CANADA COMPANY. Units affected: 51 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on April 15, 2020. Severity: Moderate. Recall number: Z-1682-2020.