Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System)
This recall has been terminated (originally issued November 28, 2006).
- Company
- Nihon Kohden America Inc
- Recall Initiated
- August 23, 2006
- Posted
- November 28, 2006
- Terminated
- May 23, 2008
- Recall Number
- Z-0218-2007
- Quantity
- 97 units in the U.S.
- Firm Location
- Foothill Ranch, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide.
Lot / Code Info
Any serial numbers up to 02160
Root Cause
Other
Action Taken
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.