Recall Z-1966-2020 ยท OBP Transcranial Magnetic Stimulator
The Magstim Company Limited
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.
| Date | Mar 23, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 you |
| Quantity | 71 units total |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051864 | MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00 The Magstim Company , Ltd., Dec 21, 2005 |
| K143531 | Rapid Therapy System Magstim Company Limited, May 8, 2015 |
| K162935 | Rapid2 Therapy System Magstim Company, Ltd., Mar 10, 2017 |
| K180907 | HORIZON TMS Therapy System Magstim Company, Ltd., Aug 3, 2018 |
| K182853 | HORIZON TMS Therapy System Magstim Company, Ltd., Mar 15, 2019 |
| K183376 | HORIZON TMS Therapy System with Navigation Magstim Company, Ltd., Apr 3, 2019 |