FDAMarch 23, 2020device
Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.
What to do
FDA enforcement status: Terminated
Brands named
magstim
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDANeurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve (VII), during ENT surgical procedures.2020-12-08
- FDANeurosign V4 Intraoperative Nerve monitor family of devices.2020-06-23
- FDARapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.2020-03-23
- FDAHORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)2018-10-25
- FDAMagstim 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 antidep...2017-09-28
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