PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: March 29, 2017 Initiated: September 22, 2015 #Z-1517-2017

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
Merge Healthcare, Inc.
Units Affected
89 sites potentially have the affected software
Distribution
US Nationwide Distribution.
Location
Hartland, WI

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Merge Healthcare, Inc.. Units affected: 89 sites potentially have the affected software.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 29, 2017. Severity: Moderate. Recall number: Z-1517-2017.

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