Home / Recalls / Medical Devices
Nihon Kohden America Inc recalls MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B,
Recalled February 24, 2016 · FDA recall Z-0817-2016 · Nihon Kohden America
Hazard
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 Class II
Units
477 units total (137 units in US)
Sold at
Worldwide distribution. US nationwide, Australia, Austria, France, Germany, Greece, Japan, Romania, South Africa, South Korea, Spain, and United Kingdom.
Description
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.
Product
MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)
Manufacturer(s)
Nihon Kohden America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →