Z-1965-2020 Class II Terminated
FDA device recall Z-1965-2020 was initiated by The Magstim Company Limited on Mar 23, 2020 and is designated Class II. Reason for recall: 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 recall status is terminated (terminated Sep 20, 2024). Affected quantity: 71 units total.
Recall details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- Mar 23, 2020
- Termination Date
- Sep 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71 units total
Product 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 for recall
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.
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.
Code information
Product Number: 5188-00
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1965-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026