Recall Z-1403-2017— Merge Healthcare, Inc.

Name: FDA recall Z-1403-2017
Creator: U.S. Food and Drug Administration
Published: 2016-04-04

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-04-04, terminated 2019-07-26. It names one FDA 510(k) clearance: K051649. Product: Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.. Reason: When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Terminated: 2019-07-26
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. The firm name on the label is Merge Healthcare, Hartland, WI.

Reason for recall

When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.

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