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.
FDA Recall Z-1352-2018 · Posted None
Advertisement
Recalling FirmThe Magstim Company Limited
Recall StatusTerminated
Product CodeOBP
Date Initiated2017-09-28
Date Terminated2022-06-21
Product Quantity43
Reason for Recall
Users manuals not supplied with 4800-00T US Rapid Therapy System
Firm 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
Root Cause
Employee error
Distribution Pattern
US Nationwide Distribution in the states of AR, CA, GA, KS, MA, MD, MO, NC, NJ, NW, NY, TX and Hawaii
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement