FDA recall Z-1966-2020

The Magstim Company Limited · Class II · device

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.

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

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.

Key facts

Status
Terminated
Initiation date
2020-03-23
Report date
2020-05-20
Termination date
2024-09-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Whitland, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1966-2020