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.
FDA Recall Z-1142-2017 · Posted None
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Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeHKI
Date Initiated2016-12-09
Date Terminated2018-06-19
Product Quantity182 capture stations
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.
Firm Action
Merge sent an Urgent Medical Device Recall letter on December 9, 2016.
The letter was addressed to Office Manager . The letter described the Product, Issue, Potential Harm, Containment by the Customer / User, Action by Merge and Actions by Customer. Requested customers to provide response to the "Response to this Notification is Required". If the product was further distributed advised consignees to notify them at once. For questions send an e-mail to [email protected].
E-mails to be sent to consignees on 12/19/2016. For further questions, please call (262) 367- 0700.
Root Cause
Software design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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