FDA-Device2020-05-20Class II

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.

The Magstim Company Limited
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.

Sold states
Worldwide distribution - US Nationwide distribution including in the states of AL, AR, CA, CT, TN, IL, MN, MT, NC, NJ, NY, PA, SC, TX, WA, and the countries of Cyprus, China, Iran, Saudi Arabia, UK, Italy, Malaysia, Spain, Taiwan, Vietnam, Australia, Japan, Turkey, France and Israel.
Affected count
71 units total
Manufactured in
Spring Gardens, N/A, Whitland, N/A, United Kingdom
Products
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 notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1965-2020

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