Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1142-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 9, 2016

Date Posted: February 15, 2017

Recall Number: Z-1142-2017

Event ID: 75149

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.

Status: Terminated

Product Quantity: 182 capture stations

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.

Voluntary or Mandated:

Voluntary: Firm initiated