The Recall Desk
HighFDA (Devices)·Z-0952-2021·Announced 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.

What this means for you

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
Hazard
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

Distributed in 6 states:

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