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.
Reported: February 10, 2021 Initiated: December 18, 2020 #Z-0952-2021
Product 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.
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
Details
- Recalling Firm
- Topcon Medical Systems, Inc.
- Units Affected
- 13 units
- Distribution
- AZ, MO, NC, NY, PA, TX
- Location
- Oakland, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Topcon Medical Systems, Inc.. Units affected: 13 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 10, 2021. Severity: Moderate. Recall number: Z-0952-2021.
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