Recall Z-1415-2017— Merge Healthcare, Inc.

Name: FDA recall Z-1415-2017
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 2017-03-20. It names one FDA 510(k) clearance: K051649. Product: Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.. Reason: A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Terminated: 2017-03-20
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 using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.

Reason for recall

A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.

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