Z-1138-2019 Class II Terminated
FDA device recall Z-1138-2019 was initiated by Topcon Medical Systems, Inc. on March 6, 2019 and is designated Class II. 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 displaye… The recall status is terminated (terminated July 17, 2019). Affected quantity: 450 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2019
- Initiation Date
- March 6, 2019
- Termination Date
- July 17, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 450 units
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.
Distribution Pattern
Nationwide
Code Information
System Version 1.53