| Class 2 Device Recall Accessories used with MEE1000A Neuromaster | |
Date Initiated by Firm | January 19, 2012 |
Date Posted | February 17, 2016 |
Recall Status1 |
Terminated 3 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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = GWF
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