Class 2 Device Recall Merge Eye Station

• Date Initiated by Firm: December 09, 2016
• Create Date: February 06, 2017
• Recall Status: Terminated on June 19, 2018
• Recall Number: Z-1142-2017
• Recall Event ID: 75149
• 510(K)Number: K913929
• Product Classification: Camera, ophthalmic, ac-powered - Product Code HKI
• 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.
• Code Information: 136 T1700 Capture Stations 46 T5810 Capture Stations
• Recalling Firm/ Manufacturer: Merge Healthcare, Inc.; 900 Walnut Ridge Dr; Hartland WI 53029-8347
• For Additional Information Contact: 262-367-0700
• Manufacturer 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.
• FDA Determined Cause: Software design
• 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 recall@merge.com. E-mails to be sent to consignees on 12/19/2016. For further questions, please call (262) 367- 0700.
• Quantity in Commerce: 182 capture stations
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HKI