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.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for diagnostic software. The hazard is potential for clinician misinterpretation due to a display that implies clinical correlations unsupported by evidence. This is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Topcon Medical Systems' IMAGEnet 6 Ophthalmic Data System is a software program used for collecting, storing, and managing digital images, patient data, and clinical information from ophthalmic devices. The system is intended for processing and displaying ophthalmic images and optical coherence tomography data.
The recall addresses an issue in the Hood Report feature. The software overlays visual field test locations on a probability map in a manner that can imply a structure-function correlation for which clinical evidence is not provided. This presentation may mislead clinicians in their interpretation of the data.
3,144 units were distributed nationwide. Clinicians should be aware of this presentation issue when interpreting Hood Report displays.
The recalled product
- 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…
- Manufacturer
- Topcon Medical Systems, Inc.
- Affected units
- 3,144
Distribution
Distributed nationwide across the United States.
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