Recall Z-1138-2019— Topcon Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Topcon Medical Systems, Inc., initiated 2019-03-06, terminated 2019-07-17. It names one FDA 510(k) clearance: K171370. 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.. 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..
- Recalling firm
- Topcon Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-06
- Terminated
- 2019-07-17
- Firm location
- Oakland, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.