Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System)
FDA Recall Z-0218-2007 · Posted 2006-11-28
Recalling FirmNihon Kohden America Inc
Recall StatusTerminated
Product CodeGWF
Date Initiated2006-08-23
Date Terminated2008-05-23
Product Quantity97 units in the U.S.
Reason for Recall
When the device is subject to physical shock, such as a drop to the floor, it may output a different value from the preset value. This may result in a superficial burn on the patient if the stimulation is done for a long time.
Firm Action
All customers will be called by phone, then faxed the Product Notification starting 09/01/2006
Customers were instructed to indicate the serial numbers on each of your MS-210BK stimulators and fax the MS-210BK PRODUCT RECALLREPLACEMENT letter back to Nihon Kohden at: 949-580-15550 or email to [email protected]. Upon receipt of this letter, Nihon Kohden''s customer service department will send a replacement unit.
Root Cause
Other
Distribution Pattern
Nationwide.
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.