Home / Recalls / Topcon Medical Systems, Inc. / Z-0952-2021

Z-0952-2021 Class II Terminated

Recalled by Topcon Medical Systems, Inc. — Oakland, NJ

Recall Details

Product Type: Devices
Report Date: February 10, 2021
Initiation Date: December 18, 2020
Termination Date: October 19, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 13 units

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.

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

Distribution Pattern

AZ, MO, NC, NY, PA, TX

Code Information

Software Version 3.1