Home / Recalls / The Magstim Company Limited / Z-1352-2018

Z-1352-2018 Class II Terminated

Recalled by The Magstim Company Limited — Whitland

Recall Details

Product Type
Devices
Report Date
April 18, 2018
Initiation Date
September 28, 2017
Termination Date
June 21, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
43

Product Description

Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main Filters Product Usage For the treatment of major depressive disorders in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

Reason for Recall

Users manuals not supplied with 4800-00T US Rapid Therapy System

Distribution Pattern

US Nationwide Distribution in the states of AR, CA, GA, KS, MA, MD, MO, NC, NJ, NW, NY, TX and Hawaii

Code Information

Part # 4800-00T

Other recalls by The Magstim Company Limited

  • Z-0869-2021 Class II — Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Us (December 8, 2020)
  • Z-2884-2020 Class II — Neurosign V4 Intraoperative Nerve monitor family of devices. (June 23, 2020)
  • Z-1966-2020 Class II — Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treat (March 23, 2020)
  • Z-1965-2020 Class II — Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for (March 23, 2020)
  • Z-0836-2019 Class II — HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.) (October 25, 2018)