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Terminated

Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.

FDA Recall Z-1246-2017 · Posted None

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeNFJ
Date Initiated2016-03-28
Date Terminated2020-04-17
Product Quantity1,627 sites potentially have the affected versions

Reason for Recall

Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN)

Firm Action

The recalling firm issued a letter dated 3/28/2016 via e-mail. If no email address was available, the letters were issued via certified mail. A follow-up letter dated 7/11/2016 was also issued.

Root Cause

Device Design

Distribution Pattern

Distribution was nationwide to medical facilities. There was also government and foreign distribution, including Canada.

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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