Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential
FDA device recall Z-0218-2007 · posted 2006-11-28 · Terminated
Recall details
- Recalling firm
- Nihon Kohden America Inc
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GWF
- Quantity affected
- 97 units in the U.S.
- Distribution
- Nationwide.
- Date initiated
- 2006-08-23
- Date posted
- 2006-11-28
- Date terminated
- 2008-05-23
- Location
- Foothill Ranch, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES (K991899) | Nihon Kohden America, Inc. | 1999-09-01 |