FDA recall Z-0952-2021

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 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

AZ, MO, NC, NY, PA, TX

Key facts

Status

Terminated

Initiation date

2020-12-18

Report date

2021-02-10

Termination date

2022-10-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Oakland, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0952-2021