The Recall Desk

FDA (Devices) recall action 85393

The Magstim Company Limited recalled 2 products on 2020-05-20

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-05-20
Critical
0
Units
142

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2020-05-20

    Magstim Horizon PSU Stim Interconnecting Cable Recalled for Potential Failure

    The Magstim Company Limited is recalling 71 Horizon PSU Stim Interconnecting Cables because the high-voltage cable may fail. The device is used for treating Major Depressive Disorder.

    Product
    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.
    Category
    Distribution
    16 states
  • HighFDA (Devices)··2020-05-20

    Magstim Recalls Rapid2 Stim Interconnecting Cables Due to Potential Failure

    The Magstim Company Limited is recalling 71 Rapid2 PSU Stim Interconnecting Cables because the high-voltage cable may fail. The recall covers units distributed worldwide.

    Product
    Rapid2 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.
    Category
    Distribution
    16 states