Recall Z-1142-2017— Merge Healthcare, Inc.

Name: FDA recall Z-1142-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-09

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-12-09, terminated 2018-06-19. It names one FDA 510(k) clearance: K913929. Product: Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.. Reason: Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the intended use of the product. Merge is recalling product from the field to reduce the risk to patient health..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-12-09
Terminated: 2018-06-19
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

1 on FDA's record

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. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.

Reason for recall

Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the intended use of the product. Merge is recalling product from the field to reduce the risk to patient health.

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