Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Recall
- Recall Number
- Z-1965-2020
- Event Number
- 85393
- Firm
- The Magstim Company Limited Spring Gardens Whitland United Kingdom
- FEI Number
- 3002808356
- Product Code
- OBP
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- March 23, 2020
- Terminated
- September 20, 2024
Description
Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.
The Magstim Company Ltd notified customers on about 3/23/2020 via URGENT FIELD SAFETY NOTICE Medical Device Recall letter. The letter instructed customers to identify all affected products at their facility, raise awareness to all those who need to be aware within their organization, notify customers if the product was further distributed, and complete and return the provided acknowledgement form, so Magstim Company can contact them to arrange replacement of the cable. Once customers have returned the acknowledgement form, Magstim Company will arrange for a new cable to be sent to you or your technical personnel. This will be accompanied by instructions on how to install the new cable. Magstim Technical Service Team can guide you through the installation via telephone or video call. This to limit transmission during the current pandemic COVID-19.
Worldwide distribution - US Nationwide distribution including in the states of AL, AR, CA, CT, TN, IL, MN, MT, NC, NJ, NY, PA, SC, TX, WA, and the countries of Cyprus, China, Iran, Saudi Arabia, UK, Italy, Malaysia, Spain, Taiwan, Vietnam, Australia, Japan, Turkey, France and Israel.
71 units total