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Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStatio...

FDA Recall #Z-1142-2017 — Class II — December 9, 2016

Recall #Z-1142-2017 Date: December 9, 2016 Classification: Class II Status: Terminated

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.

Recalling Firm

Merge Healthcare, Inc. — Hartland, WI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

182 capture stations

Distribution

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.

Code Information

136 T1700 Capture Stations 46 T5810 Capture Stations

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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