RecallRadar

FDA Device recall Z-1352-2018

Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main…

On 2018-04-18 the FDA classified a Class II recall of Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main… by The Magstim, citing users manuals not supplied with 4800-00T US Rapid Therapy System.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1352-2018
ClassificationClass II
Statusterminated
Initiated2017-09-28
Published2018-04-18
Last updated2026-09-13 11:54 UTC
CompanyThe Magstim
DistributionUS

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.

Reason

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

Identifiers

code_infoPart # 4800-00T

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1352-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.