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Recall Observatory FDA recall evidence

Device 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 Stations.

Z-1142-2017

December 09, 2016

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 75149
Status
Terminated
Classification
Class II
Quantity
182 capture stations
Official record key
device-enforcement:Z-1142-2017

Official wording

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.

Code information: 136 T1700 Capture Stations 46 T5810 Capture Stations

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.