RegWardenFDA facility compliance records
Facility

MAGSTIM INC

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

Activity by year

FDA actions on record by year2016: 1 inspections; 2017: 1 recalls; 2018: 1 recalls; 2020: 3 recalls120161201712018201932020202120222023202420252026
  • Recalls (5)
  • Inspections (1)

Devices registered here (2)

  • Non-Normalizing Quantitative Electroencephalograph Software
    Product code OLT (opens in a new tab) · Class II · Neurology · 21 CFR 882.1400
  • Full-Montage Standard Electroencephalograph
    Product code GWQ (opens in a new tab) · Class II · Neurology · 21 CFR 882.1400

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

FDA inspections (1)

  • VAI2016-06-17
    Voluntary Action Indicated · Bioresearch Monitoring · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

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. “MAGSTIM INC (FEI 3001090553) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001090553-magstim-inc/

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