Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1091-2017)

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. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure

Product Classification:

Class II

Date Initiated: March 28, 2016

Date Posted: February 1, 2017

Recall Number: Z-1091-2017

Event ID: 76214

Reason for Recall:

There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.

Status: Terminated

Product Quantity: 242 sites potentially have the affected versions

Code Information:

Versions 6.10, 6.10.1, 6.10.2, 6.10.3, 7.10, 7.20, 7.20.1, 8.10.0, 8.20, 9.10.0, 9.20, 9.20.2, 9.20.3, 9.30, 9.40, 9.40.1, 9.40.2, and 9.40.3

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated