Dfc-1024 & Dfc-512 Digital Imaging System

• • Terminated Z-1017-2017 FDA Class II ·initiated 9 Dec 2016

  This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.

• • Terminated Z-1142-2017 FDA Class II ·initiated 9 Dec 2016

  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.

• • Terminated Z-1681-2017 FDA Class II ·initiated 4 Apr 2016 ·on shared 510(k) K913929

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

• • Terminated Z-1828-2017 FDA Class II ·initiated 4 Apr 2016 ·on shared 510(k) K913929

  During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently.

• • Terminated Z-1246-2017 FDA Class II ·initiated 28 Mar 2016 ·on shared 510(k) K913929

  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)

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K913929 ↗

FDA Product Code

HKI

Device Class

Class II

Regulation

21 CFR Part 886.1120

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Ois Eyescan Portable Modular Imaging System, Model Ois Eyescan

  Class II

  FDA 510(k) K092374 Active Cleared 17 Nov 2009

• Winstation Retinal Imager

  Class II

  FDA 510(k) K982689 Active Cleared 23 Oct 1998

• Ois Symphony Image Managment System

  Class II

  FDA 510(k) K110006 Active Cleared 18 May 2011

• Glaucoma-Scope

  Class II

  FDA 510(k) K913118 Active Cleared 9 Oct 1991