Facility

THE MAGSTIM COMPANY LTD.

5 recall(s) on record — most severe on record: Class II.

Key facts

5recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002808356
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	Spring Gardens Carmarthenshire Wales, GB SA34 0HR
Registration status	Active · expires 2026
Parent company	The Magstim Company Ltd. (owner-operator 8021774)
Brand names	HORIZON® Therapy System

Activity by year

Recalls (5)

Devices registered here (1)

Transcranial Magnetic Stimulator
Product code OBP (opens in a new tab) · Class II · Neurology · 21 CFR 882.5805

Recalls & enforcement

Class IITerminated2020-12-08
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 120…
Class IITerminated2020-06-23
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.
Class IITerminated2020-03-23
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.
Class IIOngoing2018-10-25
A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balance Cable of the Ez Arm.
Class IITerminated2017-09-28
Users manuals not supplied with 4800-00T US Rapid Therapy System

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “THE MAGSTIM COMPANY LTD. (FEI 3002808356) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002808356-the-magstim-company-ltd/

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