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Recall Observatory FDA recall evidence

Device 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.

Z-1965-2020

March 23, 2020

Class II

Product summary

Firm
The Magstim Company Limited
Event
Event 85393
Status
Terminated
Classification
Class II
Quantity
71 units total
Official record key
device-enforcement:Z-1965-2020

Official wording

Reason: 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.

Code information: Product Number: 5188-00

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.