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 Initiated
- September 28, 2017
- Terminated
- June 21, 2022
- Recall Number
- Z-1352-2018
- Quantity
- 43
Reason for Recall
Users manuals not supplied with 4800-00T US Rapid Therapy System
Distribution
US Nationwide Distribution in the states of AR, CA, GA, KS, MA, MD, MO, NC, NJ, NW, NY, TX and Hawaii
Lot / Code Info
Part # 4800-00T
Root Cause
Employee error
Action Taken
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
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