FDAFDA · Food and drugs·Recall number Z-1517-2017
Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.
Published March 29, 2017 · Recall initiated: September 22, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Merge Healthcare, Inc.
- Distributor
- US Nationwide Distribution.
- Lot
- Versions 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, and 9.0.8
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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