FDAFDA · Food and drugs·Recall number Z-1142-2017
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.
Published February 15, 2017 · Recall initiated: December 9, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Merge Healthcare, Inc.
- Distributor
- 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.
- Lot
- 136 T1700 Capture Stations 46 T5810 Capture Stations
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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