Recall Z-0952-2021— Topcon Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Topcon Medical Systems, Inc., initiated 2020-12-18, terminated 2022-10-19. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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.
- Recalling firm
- Topcon Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-12-18
- Terminated
- 2022-10-19
- Firm location
- Oakland, NJ, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.