IMAGEnet 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.
FDA Recall Z-1138-2019 · Posted 2019-04-12
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Recalling FirmTopcon Medical Systems, Inc.
Recall StatusTerminated
Product CodeNFJ
Date Initiated2019-03-06
Date Terminated2019-07-17
Product Quantity450 units
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.
Firm Action
Topcon 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 [email protected]
Root Cause
Labeling design
Distribution Pattern
Nationwide
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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