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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software display error that could lead to data confusion, but no injuries or illnesses have been reported, fitting the criteria for a moderate severity recall.
Plain-English summary
Topcon Medical Systems, Inc. is recalling 450 units of the IMAGEnet 6 Ophthalmic Data System, System Version 1.53. The software is intended for the collection, storage, and management of digital images, patient data, diagnostic data, and clinical information from Topcon devices. The recall is nationwide.
The recall was initiated because of a software defect where patient identification information may be displayed incorrectly. Specifically, if a user selects a patient and then selects a different patient before the first patient's thumbnails have finished loading, the first patient's thumbnails may appear on the screen with the second patient's name and ID. This could lead to confusion regarding which patient's data is being viewed.
Healthcare providers using this software should stop using the affected version and contact Topcon Medical Systems for instructions on how to resolve the issue. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- 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…
- Manufacturer
- Topcon Medical Systems, Inc.
- Affected units
- 450
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- System Version 1.53
Distribution
Distributed nationwide across the United States.
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