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U.S. Department of Health and Human Services

Class 2 Device Recall Neuropack Evoked Potential and EMG Measuring System

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  Class 2 Device Recall Neuropack Evoked Potential and EMG Measuring System see related information
Date Initiated by Firm August 23, 2006
Date Posted November 28, 2006
Recall Status1 Terminated 3 on May 23, 2008
Recall Number Z-0218-2007
Recall Event ID 36394
510(K)Number K991899  
Product Classification Constant current stimulation unit - Product Code GWF
Product Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System)
Code Information Any serial numbers up to 02160
Recalling Firm/
Manufacturer		 Nihon Kohden America Inc
90 Icon
Foothill Ranch CA 92610-3000
For Additional Information Contact Serrah Namini
949-580-1555 Ext. 4401
Manufacturer 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 Determined
Cause 2		 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 in Commerce 97 units in the U.S.
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GWF and Original Applicant = NIHON KOHDEN AMERICA, INC.
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