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
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