Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1415-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.

Product Classification:

Class II

Date Initiated: April 4, 2016

Date Posted: March 29, 2017

Recall Number: Z-1415-2017

Event ID: 76401

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.

Status: Terminated

Product Quantity: 17 sites potentially have the affected versions

Code Information:

Version 9.0.9 and earlier using EchoIMS.

Distribution Pattern:

US Distribution was made to medical facilities in CA, FL, IL, MD, MO, OH, OK, TX, VT, and WI. Military distribution was also made.

Voluntary or Mandated:

Voluntary: Firm initiated