FDA Medical Device Recalls (openFDA)
Nihon Kohden America Inc: Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System)
- Recall number
- Z-0218-2007
- 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)
- Status
- Terminated
- Initiated
- 2006-08-23
- Posted
- 2006-11-28
- Terminated
- 2008-05-23
- Reason
- 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.
- 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 customerservice@nkusa.com. Upon receipt of this letter, Nihon Kohden''s customer service department will send a replacement unit.
- Quantity
- 97 units in the U.S.
- Distribution
- Nationwide.
- Lot, serial or model codes
- Any serial numbers up to 02160
- 510(k) numbers
- ["K991899"]
- PMA numbers
- not on file
- Product code
- GWF
- Firm FEI
- 2080783
- Firm city
- Foothill Ranch
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28