FDAFDA · Food and drugs·Recall number Z-1682-2020
McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
Published April 15, 2020 · Recall initiated: February 10, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CHANGE HEALTHCARE CANADA COMPANY
- Distributor
- Distribution US nationwide, Canada and the United Kingdom
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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