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Terminated

Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).

FDA Recall Z-1681-2017 · Posted 2017-03-13

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

Reason for Recall

The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.

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.

Root Cause

Software Design Change

Distribution Pattern

Distribution was made to medical facilities nationwide. Government distribution was made. Foreign distribution was made to Canada, as well as other countries. There was no military 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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