IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for ...
FDA Device Recall #Z-1138-2019 — Class II — March 6, 2019
Recall Summary
| Recall Number | Z-1138-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 6, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Topcon Medical Systems, Inc. |
| Location | Oakland, NJ |
| Product Type | Devices |
| 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
Lot / Code Information
System Version 1.53
Other Recalls from Topcon Medical Systems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0362-2025 | Class II | The IMAGEnet 6 Ophthalmic Data System is a soft... | Sep 17, 2024 |
| Z-0952-2021 | Class II | Harmony Referral System (aka Harmony RS)/ Medic... | Dec 18, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.