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Lower risk Medical device recall · FDA · Published September 28, 2017

Magstim Rapid Therapy System: Missing User Manuals Risk

Magstim recalls 4800-0:0T Rapid Therapy System units due to missing user manuals. This could affect safe use of the device for treating depression.

🇺🇸 FDA recall #Z-1352-2018Medical deviceMagstim ›
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Recalling firmThe Magstim Company LimitedSpring Gardens · Whitland, United Kingdom
✎ GovInfoNow plain-language explainer

What happened, in plain English

Magstim is recalling a specific model of Rapid Therapy System for depression treatment because user manuals are missing. Without instructions, users might not operate the device safely. Read more at govinfonow.com/recall/72935-magstim-rapid-therapy-system-missing-user-manuals-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/72935-magstim-rapid-therapy-system-missing-user-manuals-risk · Updated September 17, 2026 · FDA enforcement record: FDA #Z-1352-2018

Cite this page

“Magstim Rapid Therapy System: Missing User Manuals Risk.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72935-magstim-rapid-therapy-system-missing-user-manuals-risk. Based on FDA recall #Z-1352-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1352-2018%22&limit=1).

Why it’s dangerous

The device requires detailed instructions for safe use. Without user manuals, users may not operate it correctly, potentially leading to unsafe use. However, the hazard is not described as causing serious injury in normal use.

Who’s affected

Adult patients using this device for depression treatment who received the 4800-00T model without user manuals. Those who have the device but don't know it's affected are most at risk.

How to tell if you have this one

Check if your device has the model number 4800-00T. The product includes Rapid Mainframe, Rapid Single Power Supply Unit, Rapid User Interface, and Air Film Coil. It was sold for treating depression in adults.

  • Brand
    Magstim
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check for User Manuals

    Look for the user manual with the device. If missing, contact Magstim for instructions.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 12 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “US Nationwide Distribution in the states of AR, CA, GA, KS, MA, MD, MO, NC, NJ, NW, NY, TX and Hawaii” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arkansas, California, Georgia, Hawaii, Kansas, Maryland, Massachusetts, Missouri, New Jersey, New York, North Carolina, Texas.

Recall timeline

FDA terminated this recall 4.7 years after the firm started it.

1. Firm started the recall: Sep 28, 201712. FDA classified it Class II: Apr 10, 201823. Published in FDA’s Enforcement Report: Apr 18, 201834. FDA terminated the recall: Jun 21, 2022420172022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1352-2018 (September 28, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1352-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA