Device product
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.
Z-1517-2017
Product summary
- Event
- Event 76719
- Status
- Terminated
- Classification
- Class II
- Quantity
- 89 sites potentially have the affected software
- Official record key
device-enforcement:Z-1517-2017
Official wording
Reason: 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.
Code information: 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
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Unknown
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.