FDA-Device2021-02-10Class II
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.
Topcon Medical Systems, Inc.
Hazard
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
Sold states
AZ, MO, NC, NY, PA, TX
Affected count
13 units
Manufactured in
111 Bauer Dr, Oakland, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0952-2021Don't want to check this manually?
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