Device product
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.
Z-1138-2019
Product summary
- Event
- Event 82322
- Status
- Terminated
- Classification
- Class II
- Quantity
- 450 units
- Official record key
device-enforcement:Z-1138-2019
Official wording
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.
Code information: System Version 1.53
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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.