Harmony recall
Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professionals and…
Why was Harmony 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Version 3.1
- Product
- Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professionals and…
- Recalling firm
- Topcon Medical Systems, Inc.
- Quantity
- 13 units
- Distribution
- AZ, MO, NC, NY, PA, TX
- Recall date
- February 10, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)