Device product
Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems 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-0730-2017
Product summary
- Event
- Event 75714
- Status
- Terminated
- Classification
- Class II
- Quantity
- 116 sites potentially have the effected versions
- Official record key
device-enforcement:Z-0730-2017
Official wording
Reason: Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost.
Code information: Versions V10.1 and 10.1.1
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost.