Z-0218-2007

Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked...

Name: Z-0218-2007 Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked...
Creator: Nihon Kohden America Inc
Published: 2006-08-23
License: https://open.fda.gov/license/

Nihon Kohden America Inc / initiated 2006-08-23 / Terminated

FDA source

Nihon Kohden America Inc began a recall of Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System) on 2006-08-23. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0218-2007
Status: Terminated
Initiated: 2006-08-23
Posted: 2006-11-28
Terminated: 2008-05-23
Recalling firm: Nihon Kohden America Inc
Product: Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System)
Product code: GWF Stimulator, Electrical, Evoked Response
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.
FDA root cause: Other
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.
Quantity in commerce: 97 units in the U.S.
Distribution: Nationwide.
Product codes and lots: Any serial numbers up to 02160

Product code GWF

K991899Class IINihon Kohden Meb-2200A Neuropack Evoked Potential & EMG Measuring System with AccessoriesNihon Kohden America, Inc. / cleared 1999-09-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)