Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1697-2017)

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:

iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data

Product Classification:

Class II

Date Initiated: April 4, 2016

Date Posted: April 5, 2017

Recall Number: Z-1697-2017

Event ID: 76851

Reason for Recall:

The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting in comparison studies not being available for physician review to determine the progression of disease.

Status: Terminated

Product Quantity: 298 sites potentially have the affected versions (290 of those in US)

Code Information:

Versions 8.30, 8.30.2, 8.40.0, 8.40.1, 8.40.2, 8.40.2.1, 8.40.2.2, 8.70, 8.80, 8.80.0.1, 8.80.0.2, 8.80.1.1, 8.80.2, 9.0.0, 9.0.0.1, 9.1.0, 9.1.1, 9.1.2, 9.1.2.1, 9.2.0, 9.3.0, 9.3.1, 9.4, 9.4.1, 9.4.2, 9.4.2.1, and 9.4.3.

Distribution Pattern:

Worldwide Distribution - US (nationwide) and Internationally to Canada, Belgium, Australia, Jordan, and the UK..

Voluntary or Mandated:

Voluntary: Firm initiated