Reported Feb 10, 2021 · Terminated
Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained…
Topcon Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Topcon Medical Systems, Inc. · 111 Bauer Dr · Oakland, NJ · 07436-3123
Is this the product you have?
- Harmony Referral System (aka Harmony RS)/ Medical
- Device Data System - Product Usageintended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms and patient information
- Lot codes and dates
- Software Version 3.1
- Amount recalled
- 13 units
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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