medical Class II Updated 2021-02-10

Topcon Medical Systems, Inc. recalls Harmony Referral System (aka Harmony RS)/ Medical Device Da

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Affected States: AZ, MO, NC, NY, PA, TX
Lot/Code Info: Software Version 3.1
View official government recall

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