Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0554-2016)

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 Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.

Product Classification:

Class II

Date Initiated: October 26, 2015

Date Posted: January 6, 2016

Recall Number: Z-0554-2016

Event ID: 72661

Reason for Recall:

The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.

Status: Terminated

Product Quantity: 2

Code Information:

Merge Hemo with software versions 10.0 LA

Distribution Pattern:

Distributed in the states of IL, NC, and VT.

Voluntary or Mandated:

Voluntary: Firm initiated