Recall Z-1138-2019 ยท NFJ System, Image Management, Ophthalmic
Topcon Medical Systems, Inc.
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.
| Date | Apr 12, 2019 (initiated Mar 6, 2019) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling design |
| 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 TMSservice@topcon.com |
| Quantity | 450 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171370 | IMAGEnet 6 Ophthalmic Data System Topcon Corporation, Nov 1, 2017 |