Reported Apr 24, 2019 · Terminated
IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection,…
Topcon Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Topcon Medical Systems, Inc. · 111 Bauer Dr · Oakland, NJ · 07436-3123
Is this the product you have?
- 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.
- Lot codes and dates
- System Version 1.53
- Amount recalled
- 450 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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