IMAGEnet 6 v1 — Class II medical device recall Z-1138-2019
Terminated recall by Topcon Medical Systems, Inc., reported 2019-04-24, distributed nationwide. When a patient is selected in the patient data and another patient is selected prior to the display of the pri
| Recall number | Z-1138-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Topcon Medical Systems, Inc., Oakland, NJ, United States |
| Recall initiated | 2019-03-06 |
| Classified | 2019-04-12 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2019-07-17 |
| Distributed | Nationwide (US) |
| Quantity | 450 units |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1138-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.