Recall Z-1046-2017— Merge Healthcare, Inc.

Name: FDA recall Z-1046-2017
Creator: U.S. Food and Drug Administration
Published: 2016-03-28

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-03-28, terminated 2019-04-08. It names one FDA 510(k) clearance: K051649. 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.. Reason: If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original study, it is possible that not all current images will be present for review, which could result in incorrect treatment/diagnosis..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-03-28
Terminated: 2019-04-08
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K051649 — VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0Camtronics Medical Systems·cleared 2005-08-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original study, it is possible that not all current images will be present for review, which could result in incorrect treatment/diagnosis.

Data sourced from openFDA. This site is unofficial and independent of the FDA.