Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2301-2016)

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 PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

Product Classification:

Class II

Date Initiated: January 30, 2016

Date Posted: August 10, 2016

Recall Number: Z-2301-2016

Event ID: 74648

Reason for Recall:

Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.

Status: Terminated

Product Quantity: 109 sites have the affected versions

Code Information:

Versions: V6.0 MR4 CU 1-11, 6.1.0, 6.1.1, 6.1.1.1, 6.1.2, 6.1.3, 6.1.3.1, 6.2.0, 6.2.1, 6.2.2, 6.2.2.1, and 6.2.3.

Distribution Pattern:

Worldwide Distribution -- USA, New Zealand, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated