Z-1352-2018Class II

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

Name: Z-1352-2018 Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User...
Creator: The Magstim Company Limited
Published: 2017-09-28
License: https://open.fda.gov/license/

Magstim Inc. / initiated 2017-09-28 / Terminated / root cause: manufacturing process

FDA source

The Magstim Company Limited began a recall of Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main Filters Product... on 2017-09-28. FDA classified it as Class II and gives the reason as "Users manuals not supplied with 4800-00T US Rapid Therapy System". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1352-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-28
Posted: 2018-04-11
Terminated: 2022-06-21
Recalling firm: Magstim Inc.
Product: 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.
Product code: OBP Transcranial Magnetic Stimulator
Reason for recall: Users manuals not supplied with 4800-00T US Rapid Therapy System
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On September 28, 2017 the recalling firm sent a Field Safety Notice that included the Operating Manual to all their customers involved in this event. An Acknowledgement card was attached to the letter to be sent back to the recalling firm informing that they received the Operating Manual
Quantity in commerce: 43
Distribution: US Nationwide Distribution in the states of AR, CA, GA, KS, MA, MD, MO, NC, NJ, NW, NY, TX and Hawaii
Product codes and lots: Part # 4800-00T

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1352-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1352-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10

Product code OBP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)