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U.S. Department of Health and Human Services

Class 2 Device Recall Merge Eye Station

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  Class 2 Device Recall Merge Eye Station see related information
Date Initiated by Firm December 09, 2016
Create Date January 12, 2017
Recall Status1 Terminated 3 on March 24, 2021
Recall Number Z-1017-2017
Recall Event ID 75602
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). Versions: 11.6.0 and prior
Code Information Merge Eye Station software versions: 11.6.0 and prior
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		 This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.
FDA Determined
Cause 2		 Software design
Action Consignees were sent on 12/9/2016 a Merge "Urgent Medical Device Recall" letter. The letter was addressed to Office Manager and Recall # 216-078. The letter described the Product, Issue, Potential Harm, Containment by the Customer / User, Action by Merge and Actions by Customer. Requested consignees 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.
Quantity in Commerce 1597 (1451 US; 146 OUS)
Distribution US: Alabama, Alaska, Arizona,Arkansas, California,Colorado,Connecticut,Delaware, District of Columbia, Georgia,Hawaii, Idaho, Illinois,Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland,Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Florida, Tennessee, Wyoming. OUS: Czech Republic Algeria Belgium Brazil Canada Denmark France Germany Greece India Israel Italy Korea, Republic of Luxembourg Netherlands Poland Russian Federation Singapore 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 and Original Applicant = OPHTHALMIC IMAGING SYSTEMS
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