• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Accessories used with MEE1000A Neuromaster

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Accessories used with MEE1000A Neuromaster see related information
Date Posted February 17, 2016
Recall Status1 Terminated on February 22, 2016
Recall Number Z-0817-2016
Recall Event ID 73114
510(K)Number K051178 
Product Classification Stimulator, electrical, evoked response - Product Code GWF
Product MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)
Code Information Serial Numbers:
MS-110B: (17 units) 00013-00019, 00023- 00032
MS-120BK: (6 units) 0009- 00014
JB-116B: (31 units), 0008, 00012, 00014, 00016, 00018, 00019, 00020, 00021, 00023, 00025, 00026, 00027, 00028, 00029, 00031, 00032, 00034, 00035, 00039, 00043, 00102,00103, 00122-00128, 00134, 00135
JB-132B: (83 units) 00009, 00011, 00012, 00014, 00015, 00016, 00018, 00019, 00020, 00021, 00023, 00024, 00025, 00026, 00027, 00036, 00037, 00038, 00041, 00042, 00043, 00044, 00046, 00047, 00049, 00061, 00062, 00066, 00067, 00068, 00069,00071, 00072, 00074, 00075, 00082, 00084, 0085, 00086, 00090, 00095, 00099, 00120, 00121-00129, 00131-00147, 00149-00155, 00157, 00161, 00164-00168
Recalling Firm/
Manufacturer
Nihon Kohden America Inc
15353 Barranca Pkwy
Irvine CA 92618-2216
For Additional Information Contact
949-580-1555
Manufacturer Reason
for Recall
The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boards which were intended to provide protection from electrostatic discharge failed to prohibit unintentional current flow.
FDA Determined
Cause 2
Device Design
Action A customer notification letter dated 9/25/12 was sent to customers informing them of a potential malfunction of NIHON KOHDEN amplifier units, models JB-116B and JB-132B and Extension Unit MS-110B, used with the MEE-1000A Neuromaster Neural Function Measuring System. The letter informs the customers of the potential malfunction and that the probability that the malfunction occurs is extremely rare. The letter informs the customers of the preventive measure and the preventive corrective action. Customers are instructed to inform all potential users and operators of the Neural Function Measuring System MEE-1000A Neuromaster about the Corrective Action notice. Customers are instructed that NIHON KOHDEN technical support representative will contact them to arrange an update of their amplifier products.
Quantity in Commerce 477 units total (137 units in US)
Distribution Worldwide distribution. US nationwide, Australia, Austria, France, Germany, Greece, Japan, Romania, South Africa, South Korea, Spain, and United Kingdom.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GWF and Original Applicant = NIHON KOHDEN AMERICA, INC.
-
-