Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0664-2017)

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 FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications

Product Classification:

Class II

Date Initiated: January 30, 2016

Date Posted: December 7, 2016

Recall Number: Z-0664-2017

Event ID: 75334

Reason for Recall:

Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be processed by the rest of the LIS software.

Status: Terminated

Product Quantity: 324 sites potentially have the affected version

Code Information:

Version 1.0

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated