Nihon Kohden America Inc: Medical Device Recall in 2016 - (Recall #: Z-0817-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)

Product Classification:

Class II

Date Initiated: January 19, 2012

Date Posted: February 24, 2016

Recall Number: Z-0817-2016

Event ID: 73114

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.

Status: Terminated

Product Quantity: 477 units total (137 units in US)

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

Distribution Pattern:

Worldwide distribution. US nationwide, Australia, Austria, France, Germany, Greece, Japan, Romania, South Africa, South Korea, Spain, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated