Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2709-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.

Product Classification:

Class II

Date Initiated: February 9, 2016

Date Posted: September 7, 2016

Recall Number: Z-2709-2016

Event ID: 75027

Reason for Recall:

A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).

Status: Terminated

Product Quantity: 116 customers potentially have the affected versions

Code Information:

Versions 10.1 and 10.1.1

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated