Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 24, 2019
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.
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 th…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Topcon Medical Systems, Inc. recalled IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is inten… - a moderate-severity action.
IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is inten… was recalled by Topcon Medical Systems, Inc. in April 24, 2019. Reason: When a patient is selected in the patient data and another patient is selected prior to the display of the pr…. Check the official notice for the remedy. Verify recall #Z-1138-2019 with the FDA Devices before acting.
The recall
Topcon Medical Systems, Inc. issued this moderate-severity FDA Devices recall-When a patient is selected in the patient data and another patient is selected prior to the display of the pr….
- Moderate
- severity level
- 450 units
- affected scope
- Class II
- classification
- April 24, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1138-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1138-2019) was formally reported on April 24, 2019, with the manufacturer initiating the action on March 6, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Topcon Medical Systems, Inc. is listed as the recalling firm, operating out of Oakland, NJ. Federal records list the affected scope as 450 units.
The documented reason for this recall is: 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 pa… Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
450 units
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1138-2019 |
| Date reported | April 24, 2019 |
| Date initiated | March 6, 2019 |
| Recalling firm | Topcon Medical Systems, Inc. |
| Firm location | Oakland, NJ |
| Affected scope | 450 units |
| Distribution | Nationwide |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1138-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Topcon Medical Systems, Inc.. Units affected: 450 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2019. Severity: Moderate. Recall number: Z-1138-2019.
Where was the recalled product distributed? ▼
Distribution: Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1138-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 24, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.