The Magstim Company , Ltd. FDA Record
- Latest inspection VAI · Jun 17, 2016
- No warning letters matched by name
The Magstim Company , Ltd. has 6 FDA recalls, 5 inspections, 27 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "The Magstim Company , Ltd." is on file.
- Latest recall
- Z-0869-2021 · Class II · Dec 8, 2020
- Latest inspection
- Jun 17, 2016 · VAI
- Latest 510(k)
- Jul 3, 2025
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 6 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 27 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 5 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
The Magstim Company , Ltd.: FDA recall records per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 4 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 1 | 0 |
| 2017 | 0 | 0 | 0 | 1 | 0 |
Reviewing The Magstim Company , Ltd. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check The Magstim Company , Ltd. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0869-2021 | Class II | Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for… | Dec 8, 2020 |
| Z-2884-2020 | Class II | Neurosign V4 Intraoperative Nerve monitor family of devices. | Jun 23, 2020 |
| Z-1965-2020 | Class II | Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of… | Mar 23, 2020 |
| Z-1966-2020 | Class II | Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major… | Mar 23, 2020 |
| Z-0836-2019 | Class II | HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.) | Oct 25, 2018 |
| Z-1352-2018 | Class II | Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid… | Sep 28, 2017 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 17, 2016 | Eugene, OR | Devices | Voluntary Action Indicated (VAI) | 3001090553 |
| Apr 30, 2015 | Whitland, United Kingdom | Devices | No Action Indicated (NAI) | 3002808356 |
| Mar 27, 2015 | Eugene, OR | Devices | Voluntary Action Indicated (VAI) | 3001090553 |
| Aug 12, 2010 | Eugene, OR | Devices | Voluntary Action Indicated (VAI) | 3001090553 |
| Aug 12, 2010 | Eugene, OR | Devices | No Action Indicated (NAI) | 3001090553 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3001090553 | Eugene, OR | 4 | Jun 17, 2016 |
| FEI 3002808356 | Whitland, United Kingdom | 1 | Apr 30, 2015 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K250286 | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) | Jul 3, 2025 |
| K243869 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0… | Mar 17, 2025 |
| K241518 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0… | Aug 30, 2024 |
| K232235 | Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with… | Oct 25, 2023 |
| K223154 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with… | Mar 16, 2023 |
| K222171 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with… | Jan 13, 2023 |
| K211389 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation | Sep 14, 2021 |
| K203684 | Neurosign V4 Intraoperative Nerve Monitor | Mar 17, 2021 |
| K183376 | HORIZON TMS Therapy System with Navigation | Apr 3, 2019 |
| K182853 | HORIZON TMS Therapy System | Mar 15, 2019 |
| K181559 | Neurosign V4 Intraoperative Nerve Monitor | Nov 9, 2018 |
| K180907 | HORIZON TMS Therapy System | Aug 3, 2018 |
| K171051 | HORIZON Therapy System | Sep 13, 2017 |
| K162935 | Rapid2 Therapy System | Mar 10, 2017 |
| K143531 | Rapid Therapy System | May 8, 2015 |
| K130403 | MAGSTIM DOUBLE 70-2 COIL | Aug 23, 2013 |
| K083242 | NEUROSIGN AVALANCHE MOTOR NERVE MONITOR | Jul 29, 2009 |
| K080499 | MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 | Dec 8, 2008 |
| K071349 | NEUROSIGN LARYNGEAL ELECTRODES | Dec 12, 2007 |
| K051864 | MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00 | Dec 21, 2005 |
The Magstim Company , Ltd. and the FDA: common questions
Has The Magstim Company , Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "The Magstim Company , Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has The Magstim Company , Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "The Magstim Company , Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect The Magstim Company , Ltd.?
The most recent FDA inspection on file ended Jun 17, 2016 at Eugene, OR and was classified VAI. FDA has 5 inspections of The Magstim Company , Ltd. on file.
Has The Magstim Company , Ltd. had an FDA recall?
Yes. The Magstim Company , Ltd. has 6 FDA recalls on record. The most recent started Dec 8, 2020.
Need more than this page shows? Ask about The Magstim Company , Ltd. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.