Recall Z-1965-2020— The Magstim Company Limited
Class II · Terminated
Class II FDA medical device recall by The Magstim Company Limited, initiated 2020-03-23, terminated 2024-09-20. It names 6 FDA 510(k) clearances: K183376, K182853, K180907 and 3 more. Product: 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.. 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..
- Recalling firm
- The Magstim Company Limited
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-03-23
- Terminated
- 2024-09-20
- Firm location
- Whitland, N/A, United Kingdom
510(k) clearances named in this recall
6 on FDA's record- K183376 — HORIZON TMS Therapy System with Navigation
- K182853 — HORIZON TMS Therapy System
- K180907 — HORIZON TMS Therapy System
- K162935 — Rapid2 Therapy System
- K143531 — Rapid Therapy System
- K051864 — MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.