Recall Z-1681-2017— Merge Healthcare, Inc.

Name: FDA recall Z-1681-2017
Creator: U.S. Food and Drug Administration
Published: 2016-04-04

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-04-04, terminated 2020-06-22. It names 2 FDA 510(k) clearances: K110006, K913929. Product: Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).. Reason: The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Terminated: 2020-06-22
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 Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).

Reason for recall

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

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