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.
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: The recall involves a medical device data system where a defect caused patient records and images to be combined, creating a risk of harm through misdiagnosis or treatment errors, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Topcon Medical Systems, Inc. is recalling 13 units of the Harmony Referral System (aka Harmony RS) Medical Device Data System. The affected software is Version 3.1. The system is intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms, and patient information.
The recall was initiated because the Harmony RS integrations with Topcon equipment, specifically the TRC NW-400 and the Signal Camera, allowed user input of non-unique patient IDs. This defect caused multiple patient records and images to be combined under the first generated record.
The affected units were distributed in Arizona, Missouri, North Carolina, New York, Pennsylvania, and Texas. Healthcare facilities using this software should contact Topcon Medical Systems for instructions on how to resolve the issue.
The recalled product
- 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.
- Manufacturer
- Topcon Medical Systems, Inc.
- Category
- Medical Device — Software
- Affected units
- 13
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)
- Software Version 3.1
Distribution
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