Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended t...
FDA Recall #Z-0952-2021 — Class II — December 18, 2020
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
Recalling Firm
Topcon Medical Systems, Inc. — Oakland, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
13 units
Distribution
AZ, MO, NC, NY, PA, TX
Code Information
Software Version 3.1
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated