Company: Merge Healthcare, Inc.
Date of Enforcement Report 2/15/2017
Class lI:
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 Station
Recall Number Z-1142-2017
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/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 12/9/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
182 capture stations
DISTRIBUTION
Nationwide and Internationally
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