Topcon Medical Systems, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0952-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 18, 2020

Date Posted: February 10, 2021

Recall Number: Z-0952-2021

Event ID: 87086

Reason for Recall:

Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user input of non-unique patient IDs that caused multiple patient records and images to be combined under the first generated record

Status: Terminated

Product Quantity: 13 units

Code Information:

Software Version 3.1

Distribution Pattern:

AZ, MO, NC, NY, PA, TX

Voluntary or Mandated:

Voluntary: Firm initiated