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Terminated

iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.

FDA Recall Z-1762-2017 · Posted 2017-04-05

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLMB
Date Initiated2016-04-04
Date Terminated2020-06-15
Product Quantity333 sites potentially have the affected versions

Reason for Recall

An error message can occur resulting in the prior studies being unavailable for viewing.

Firm Action

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

Distribution was made nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government/military distribution was also made.

Official Source

View FDA Recall →

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

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