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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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…
- Manufacturer
- The Magstim Company Limited
- Category
- Medical Device — Neuromodulation
- Hazard
- 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
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