FDA Enforcement
Class II
Terminated
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.
Recall: Z-1965-2020
·
Reported May 20, 2020
Enforcement
- Recall Number
- Z-1965-2020
- Event ID
- 85393
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- The Magstim Company Limited
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 20, 2020
- Initiation Date
- March 23, 2020
- Classification Date
- May 13, 2020
- Termination Date
- September 20, 2024
- Address
- Spring Gardens, N/A, Whitland, N/A, N/A, United Kingdom
Description
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.
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 Info
Product Number: 5188-00
Distribution
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.
Quantity
71 units total