The Recall Desk

Manufacturer

Topcon Medical Systems, Inc.

3 recalls in our database name Topcon Medical Systems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2024-11-20

Of the 3 recalls from Topcon Medical Systems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • HighFDA (Devices)·Z-0362-2025·2024-11-20

    IMAGEnet 6 Ophthalmic Data System Hood Report Display Issue

    IMAGEnet 6 ophthalmic software's Hood Report overlay can mislead clinicians about clinical correlations unsupported by evidence. Affects 3,144 units nationwide.

    Product
    The 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. It is intended for processing and displaying ophthalmic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0952-2021·2021-02-10

    Topcon Harmony Referral System Recalled for Patient Data Mixing

    Topcon Medical Systems is recalling 13 Harmony Referral System units because software flaws allowed non-unique patient IDs to merge distinct patient records and images.

    Product
    Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms and patient information.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1138-2019·2019-04-24

    Topcon IMAGEnet 6 Software Recalled for Patient Data Display Error

    Topcon Medical Systems is recalling IMAGEnet 6 software due to a defect that may display incorrect patient identification information alongside thumbnails.

    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 functi
    Category
    Medical Device
    Distribution
    Distributed nationwide