IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, st
FDA device recall Z-1138-2019 · posted 2019-04-12 · Terminated
Recall details
- Recalling firm
- Topcon Medical Systems, Inc.
- 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.
- Action taken
- 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
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- NFJ
- Quantity affected
- 450 units
- Distribution
- Nationwide
- Date initiated
- 2019-03-06
- Date posted
- 2019-04-12
- Date terminated
- 2019-07-17
- Location
- Oakland, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMAGEnet 6 Ophthalmic Data System (K171370) | Topcon Corporation | 2017-11-01 |