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Terminated

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

FDA Recall Z-1697-2017 · Posted None

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLMB
Date Initiated2016-04-04
Date Terminated2020-04-10
Product Quantity298 sites potentially have the affected versions (290 of those in US)

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.

Firm Action

MERGE sent an Urgent Medical Device Recall letter dated July 11, 2016, to all affected customers. The recalling firm issued a letter dated 3/28/2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. A second letter dated 7/11/2016 was issued to nonresponders.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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