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U.S. Department of Health and Human Services

Class 2 Device Recall Topcon Ophthalmic Data System

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 Class 2 Device Recall Topcon Ophthalmic Data Systemsee related information
Date Initiated by FirmMarch 06, 2019
Date PostedApril 12, 2019
Recall Status1 Terminated 3 on July 17, 2019
Recall NumberZ-1138-2019
Recall Event ID 82322
510(K)NumberK171370 
Product Classification Antibodies, anti-actin, anti-smooth muscle - Product Code NFJ
ProductIMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices without controlling or altering the functions and parameters of any medical devices or through computerized networks.
Code Information System Version 1.53
FEI Number 2242863
Recalling Firm/
Manufacturer		 Topcon Medical Systems, Inc.
111 Bauer Dr
Oakland NJ 07436-3123
For Additional Information ContactAli Zendehdel
866-922-6278 Ext. 1
Manufacturer Reason
for Recall		When a patient is selected in the patient data and another patient is selected prior to the display of the primary patient's thumbnails is completed, then the primary patient's thumbnails are displayed with secondary patient's identification information such as name, patient's ID, etc. on the monitor screen of the PC used.
FDA Determined
Cause 2		Labeling design
ActionTopcon issued Device Correction Notice on 3/22/19 providing problem- there exists a situation in which the displayed patient name and the thumbnail image do not match and action to take.Topcon has corrected this issue in IMAGEnet 6 version 2.0.3 and will be providing a remote upgrade free of charge. Contact customer support team to schedule the upgrade at 866.922.6278 option 1 or by email at TMSservice@topcon.com
Quantity in Commerce450 units
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NFJ
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