Whitland, N/A, United Kingdom
The Magstim Company Limited recalls
5 recalls recorded since 2018, most recently on 8 December 2020. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)1
Terminated or completed4
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 8 December 2020
- Terminated
- 16 February 2023
- Reason
- A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being configured appropriately for the supply mains within the target Country. The specific deficiency includes: 1. Onboard voltage selector set to 240V (European Standard), versus 120V requirement for the United States and Canada. 2. Fuses installed in the Power Entry Module (PEM) 2xT315mAL (240V Standard), versus the 2xT630mAL requirement for a 120V mains supply.
- Distribution
- MN, NC, and NY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0869-2021
- Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve (VII), during ENT surgical procedures
Terminated Class II Medical devices
- Recall started
- 23 June 2020
- Terminated
- 16 August 2024
- Reason
- Reports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and the cable which connects the pre-amplifier to the stimulator pod, may cause damage to the internal construction of the cables.
- Distribution
- Domestic: MN International: UK, Republic of Ireland, Spain, Netherlands, Canada. (Technomed Europe distributed to: Brazil, Spain, Belgium, Chile, Greece, Poland, New Zealand, Pakistan, Portugal and Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2884-2020
- Neurosign V4 Intraoperative Nerve monitor family of devices.
Terminated Class II Medical devices
- Recall started
- 23 March 2020
- Terminated
- 20 September 2024
- 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.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1965-2020, Z-1966-2020
- 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
- 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
Ongoing Class II Medical devices
- Recall started
- 25 October 2018
- Reason
- A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balance Cable of the Ez Arm.
- Distribution
- CA, MA, MN, PA, TX, VA, WI, and WA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0836-2019
- HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
Terminated Class II Medical devices
- Recall started
- 28 September 2017
- Terminated
- 21 June 2022
- Reason
- Users manuals not supplied with 4800-00T US Rapid Therapy System
- Distribution
- US Nationwide Distribution in the states of AR, CA, GA, KS, MA, MD, MO, NC, NJ, NW, NY, TX and Hawaii
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1352-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.