Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rap...

FDA Device Recall #Z-1352-2018 — Class II — September 28, 2017

Recall Summary

Recall Number Z-1352-2018
Classification Class II — Moderate risk
Date Initiated September 28, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm The Magstim Company Limited
Location Whitland
Product Type Devices
Quantity 43

Product Description

Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main Filters Product Usage For the treatment of major depressive disorders in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

Reason for Recall

Users manuals not supplied with 4800-00T US Rapid Therapy System

Distribution Pattern

US Nationwide Distribution in the states of AR, CA, GA, KS, MA, MD, MO, NC, NJ, NW, NY, TX and Hawaii

Lot / Code Information

Part # 4800-00T

Other Recalls from The Magstim Company Limited

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Z-1965-2020 Class II Horizon PSU Stim Interconnecting Cable - Produc... Mar 23, 2020
Z-1966-2020 Class II Rapid2 PSU Stim Interconnecting Cable - Produ... Mar 23, 2020
Z-0836-2019 Class II HORIZON Ez Arm (Part of the HORIZON TMS Thera... Oct 25, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.