FDADecember 9, 2016device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

merge healthcaremerge

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear