Recall Z-0218-2007 ยท GWF Stimulator, Electrical, Evoked Response
Nihon Kohden America Inc
Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System)
| Date | Nov 28, 2006 (initiated Aug 23, 2006) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991899 | NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES Nihon Kohden America, Inc., Sep 1, 1999 |