Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0555-2016)

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 with software version 10.1 LA.

Product Classification:

Class II

Date Initiated: October 26, 2015

Date Posted: January 6, 2016

Recall Number: Z-0555-2016

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: 1

Code Information:

Merge Cardio with software version 10.1 LA. Merge Cardio is intended to allow users to review diagnostic and non-diagnostic quality images.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated