Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0399-2017)

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 LIS software.

Product Classification:

Class II

Date Initiated: March 5, 2015

Date Posted: November 23, 2016

Recall Number: Z-0399-2017

Event ID: 75419

Reason for Recall:

There is a potential for duplicate container numbers to be created for patients.

Status: Terminated

Product Quantity: 413 sites potentially have the affected software

Code Information:

Versions: 4.0.1 and earlier.

Distribution Pattern:

Distribution was made nationwide and to the Virgin Islands. Foreign distribution was made to the Bahamas.

Voluntary or Mandated:

Voluntary: Firm initiated