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Topcon Medical Systems, Inc. Recall 87086

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.

Topcon Medical Systems, Inc. Recall 87086 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0952-2021
Event ID87086
Event DescriptionHarmony 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.
Product TypeDevices
DistributionAZ, MO, NC, NY, PA, TX
Quantity13 units
Recall ReasonHarmony 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
Device Classification20210210
Device Code InfoSoftware Version 3.1
Center Classification Date20210204
Recall Initiation Date20201218
Recalling FirmTopcon Medical Systems, Inc.
Initial Notification E-Mail
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