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U.S. Department of Health and Human Services

Class 2 Device Recall Harmony Referral System (aka Harmony RS)

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 Class 2 Device Recall Harmony Referral System (aka Harmony RS)see related information
Date Initiated by FirmDecember 18, 2020
Create DateFebruary 04, 2021
Recall Status1 Terminated 3 on October 19, 2022
Recall NumberZ-0952-2021
Recall Event ID 87086
Product Classification System, image management, ophthalmic - Product Code NFJ
ProductHarmony 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.
Code Information Software Version 3.1
FEI Number 2242863
Recalling Firm/
Manufacturer		 Topcon Medical Systems, Inc.
111 Bauer Dr
Oakland NJ 07436-3123
For Additional Information Contact Ali Zendehel
866-922-6278 Ext. 1
Manufacturer 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
FDA Determined
Cause 2		Software design
ActionTopcon issued Urgent Medical Device Correction letter on 12/18/20 via email. Letter states reason for recall, health risk and action to take: Topcon Healthcare will determine original patient demographics from the image database. Using the originally entered patient information Topcon Healthcare will reprocess the merged patient recordsand images and form a unique ID by combining the ID, first & last name and date of birth. (i.e. 12345/John Doe/19860120). Customer Care team will be contacting you by phone prior to the December 22nd database correction to further describe the process and help with any questions that you may have. If you have any concerns, or would speak to Topcon Healthcare prior to this call, please feel free to contact us at 866-922-6278 (option 2).
Quantity in Commerce13 units
DistributionAZ, MO, NC, NY, PA, TX
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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