Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1403-2017)

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. The firm name on the label is Merge Healthcare, Hartland, WI.

Product Classification:

Class II

Date Initiated: April 4, 2016

Date Posted: March 15, 2017

Recall Number: Z-1403-2017

Event ID: 76590

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.

Status: Terminated

Product Quantity: 110 sites potentially have the affected versions

Code Information:

Versions 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 9.0.9, and 10.0.

Distribution Pattern:

Distribution was made to medical facilities nationwide. There was no foreign/military/government distribution.

Voluntary or Mandated:

Voluntary: Firm initiated