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Terminated

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

FDA Recall Z-0611-2017 · Posted None

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-05-25
Date Terminated2019-08-28
Product Quantity60 sites potentially have the affected versions

Reason for Recall

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

Firm Action

The recalling firm issued a notification letter dated 1/27/2016 via email or via certified mail if the firm did not have an email address for the customer. Nonresponders were issued a second letter dated 5/25/2016 on 5/26/2016.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092915CEDARA WEBACCESS, MODEL: 2.4Cedara Software Corp. · 2010-06-23

Official Source

View FDA Recall →

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

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