FDA Enforcement
Class II
Terminated
Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main Filters Product Usage For the treatment of major depressive disorders in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Recall: Z-1352-2018
·
Reported April 18, 2018
Enforcement
- Recall Number
- Z-1352-2018
- Event ID
- 79577
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- The Magstim Company Limited
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 18, 2018
- Initiation Date
- September 28, 2017
- Classification Date
- April 10, 2018
- Termination Date
- June 21, 2022
- Address
- Spring Gardens, Whitland, N/A, United Kingdom
Description
Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main Filters Product Usage For the treatment of major depressive disorders in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Reason
Users manuals not supplied with 4800-00T US Rapid Therapy System
Code Info
Part # 4800-00T
Distribution
US Nationwide Distribution in the states of AR, CA, GA, KS, MA, MD, MO, NC, NJ, NW, NY, TX and Hawaii
Quantity
43