Merge Healthcare, Inc. recalls iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archiv

Recalled April 5, 2017 · FDA recall Z-1697-2017 · Merge Healthcare

Hazard

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. · FDA Class II

Units

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

Sold at

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

Description

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.

Product

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

Manufacturer(s)

Merge Healthcare, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →