Recall Z-1352-2018 ยท OBP Transcranial Magnetic Stimulator
The Magstim Company Limited
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.
| Date | Sep 28, 2017 |
| Status | Terminated |
| Reason | Users manuals not supplied with 4800-00T US Rapid Therapy System |
| Root cause | Employee error |
| Action | On September 28, 2017 the recalling firm sent a Field Safety Notice that included the Operating Manual to all their customers involved in this event. An Acknowledgement card was attached to the letter to be sent back to the recalling firm informing that they received the Operating Manual |
| Quantity | 43 |
| Distribution | US Nationwide Distribution in the states of AR, CA, GA, KS, MA, MD, MO, NC, NJ, NW, NY, TX and Hawaii |
| FDA record | Open on fda.gov |