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Terminated

Merge Eye Station and Merge Eye Care PACS.

FDA Recall Z-1828-2017 · Posted None

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeNFJ
Date Initiated2016-04-04
Date Terminated2020-06-22
Product Quantity1,627 sites potentially have the affected versions

Reason for Recall

During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently.

Firm Action

The recalling firm issued a letter dated 3/28/2016 via email the week of 4/4/2016 or via certified mail if they did not have an email address for the customer. A second letter dated 7/11/2016 was issued to nonresponders.

Root Cause

Software in the Use Environment

Distribution Pattern

Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as to other countries. There was also government distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110006OIS SYMPHONY IMAGE MANAGMENT SYSTEMOphthalmic Imaging Systems · 2011-05-18K913929DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEMOphthalmic Imaging Systems · 1991-11-27

Official Source

View FDA Recall →

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

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