Z-1682-2020 Class II Ongoing
FDA device recall Z-1682-2020 was initiated by CHANGE HEALTHCARE CANADA COMPANY on February 10, 2020 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 51 units.
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