CLASS II Device recall · Reported 24 Apr 2019 · FDA Enforcement Report
IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System recalled
Topcon Medical Systems is recalling IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a, distributed nationwide in the US. The recall was initiated on 6 Mar 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1138-2019
- FDA event ID
- 82322
- Recalling firm
- Topcon Medical Systems, Oakland, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Mar 2019
- FDA classified
- 12 Apr 2019
- Reported
- 24 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 6 Mar 2019 | Recall initiated by company | |
| 12 Apr 2019 | Classified by FDA | +37 days |
| 24 Apr 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it 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.
Which lots are affected?
System Version 1.53
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Topcon Medical Systems
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The IMAGEnet 6 Ophthalmic Data System recalled by Topcon Medical Systems | Topcon Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Harmony Referral System (aka Harmony RS)/ Medical Device Data System recalled | Topcon Medical Systems | Other | 6 states |
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