Z-0952-2021 Class II Terminated
FDA device recall Z-0952-2021 was initiated by Topcon Medical Systems, Inc. on December 18, 2020 and is designated Class II. 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 f… The recall status is terminated (terminated October 19, 2022). Affected quantity: 13 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 10, 2021
- Initiation Date
- December 18, 2020
- Termination Date
- October 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units
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
Distribution Pattern
AZ, MO, NC, NY, PA, TX
Code Information
Software Version 3.1