FDA recall Z-1682-2020

Product

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

Distribution

Distribution US nationwide, Canada and the United Kingdom

Key facts

Status

Ongoing

Initiation date

2020-02-10

Report date

2020-04-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Richmond, British Columbia, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1682-2020