FDA recall Z-1138-2019

Topcon Medical Systems, Inc. · Class II · 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.

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

Nationwide

Key facts

Status
Terminated
Initiation date
2019-03-06
Report date
2019-04-24
Termination date
2019-07-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Oakland, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1138-2019