RegWardenFDA facility compliance records
Company

The Magstim Company Ltd.

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

Recalls by year

FDA actions on record by year2017: 1 recalls; 2018: 1 recalls; 2020: 3 recalls1201712018201932020202120222023202420252026
  • Recalls (5)

Registered facilities (2)

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. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “The Magstim Company Ltd. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-8021774-the-magstim-company-ltd/

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