Merge Healthcare, Inc. recalls Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distribu…

Recall date

December 9, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1142-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Worldwide Distribution - USA (nationwide) including the states of : CA, CO, CT, FL, HI, IL, IN, LA, MD, MA,M I, MN, MS. MK. NY, NC,ND, OH, OK, OR, PA, RI, TN, VA, WA and WV., and the countries of Canada and United Kingdom.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.