Recall Z-1246-2017— Merge Healthcare, Inc.

Name: FDA recall Z-1246-2017
Creator: U.S. Food and Drug Administration
Published: 2016-03-28

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-03-28, terminated 2020-04-17. It names 2 FDA 510(k) clearances: K110006, K913929. Product: 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.. Reason: 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).

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-03-28
Terminated: 2020-04-17
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K110006 — OIS SYMPHONY IMAGE MANAGMENT SYSTEMOphthalmic Imaging Systems·cleared 2011-05-18
K913929 — DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEMOphthalmic Imaging Systems·cleared 1991-11-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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)

Data sourced from openFDA. This site is unofficial and independent of the FDA.