The Recall Desk
LowFDA (Devices)·Z-1352-2018·Announced 2018-04-18

Magstim Rapid Therapy System Recalled for Missing User Manuals

The Magstim Company Limited is recalling 43 Magstim Rapid Therapy Systems because user manuals were not supplied with the devices.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is for a documentation issue (missing user manuals) with no reported injuries or illnesses, fitting the 'Low' severity criteria for documentation issues.

Plain-English summary

The Magstim Company Limited is recalling 43 units of the Magstim Rapid Therapy System, which includes the Rapid Mainframe, Rapid Single Power Supply Unit, Rapid User Interface, Air Film Coil, and Main Filters. The recall is due to the fact that user manuals were not supplied with the devices.

The affected devices are identified by Part # 4800-00T. These systems are used 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.

The recall covers units distributed in the states of AR, CA, GA, KS, MA, MD, MO, NC, NJ, NW, NY, TX, and Hawaii. Users should contact The Magstim Company Limited for further instructions regarding the missing documentation.

The recalled product

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 improvemen
Affected units
43

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Part # 4800-00T

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically: