FDA-Device2016-02-24Class II
MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)
Nihon Kohden America Inc
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.
Sold states
Worldwide distribution. US nationwide, Australia, Austria, France, Germany, Greece, Japan, Romania, South Africa, South Korea, Spain, and United Kingdom.
Affected count
477 units total (137 units in US)
Manufactured in
15353 Barranca Pkwy, Irvine, CA, United States
Products
MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0817-2016Don't want to check this manually?
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