Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2628-2017)

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 LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported.

Product Classification:

Class II

Date Initiated: April 15, 2016

Date Posted: July 5, 2017

Recall Number: Z-2628-2017

Event ID: 77299

Reason for Recall:

There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified.

Status: Terminated

Product Quantity: 638 sites have the potentially affected versions

Code Information:

Versions V3.7, 3.7.1, 3.7.2, 3.7.3, 3.8, 3.8.0.1, 3.8.1, 3.8.2, 3.9.1, 3.9.2, 3.9.3, 4.1, 4.1.1, 4.1.2, 4.1.3, and 4.1.4

Distribution Pattern:

Nationwide Distribution to facilities and distributors. Distribution was made to the Virgin Islands. Foreign distribution was also made. There was no military/government distribution.

Voluntary or Mandated:

Voluntary: Firm initiated