Rapid2 PSU Stim Interconnecting Cable - Product Usage: 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 Initiated
- March 23, 2020
- Terminated
- September 20, 2024
- Recall Number
- Z-1966-2020
- Quantity
- 71 units total
Reason for Recall
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.
Distribution
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.
Lot / Code Info
Product Code: 3853-00
Root Cause
Nonconforming Material/Component
Action Taken
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.