Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1778-2017)

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 Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure

Product Classification:

Class II

Date Initiated: April 4, 2016

Date Posted: April 19, 2017

Recall Number: Z-1778-2017

Event ID: 76859

Reason for Recall:

Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.

Status: Terminated

Product Quantity: 24 sites potentially have the affected versions

Code Information:

Versions 9.10.0, 9.20.0, 9.20.1, 9.20.2, 9.30.3, and 9.40.0.

Distribution Pattern:

Nationwide Distribution including AZ, CA, CO, FL, GA, KS, LA, MI, MO, OH, OK, TN, TX, VA, WA, WI, and WV.

Voluntary or Mandated:

Voluntary: Firm initiated