Recall Z-1352-2018— The Magstim Company Limited
Class II · Terminated
Class II FDA medical device recall by The Magstim Company Limited, initiated 2017-09-28, terminated 2022-06-21. It names 2 FDA 510(k) clearances: K162935, K143531. Product: 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.
- Recalling firm
- The Magstim Company Limited
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-09-28
- Terminated
- 2022-06-21
- Firm location
- Whitland, United Kingdom
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
Users manuals not supplied with 4800-00T US Rapid Therapy System
Data sourced from openFDA. This site is unofficial and independent of the FDA.