Z-1682-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2020
- Initiation Date
- February 10, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51 units
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
Distribution Pattern
Distribution US nationwide, Canada and the United Kingdom
Code Information
McKesson Cardiology Software Versions: 13.2.1 HF1, 13.2.1 HF2, 14.0, 14.0 HF1, 14.0 HF2; Change Healthcare Software Versions: 14.1.1, 14.2