Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0611-2017)

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:

iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.

Product Classification:

Class II

Date Initiated: May 25, 2016
Date Posted: November 23, 2016
Recall Number: Z-0611-2017
Event ID: 75497
Reason for Recall:

Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.

Status: Terminated
Product Quantity: 60 sites potentially have the affected versions
Code Information:

Versions 3.0.1, 3.1, and 3.2

Distribution Pattern:

Distribution was made to medical facilities nationwide. Foreign distribution was also made.

Voluntary or Mandated:

Voluntary: Firm initiated