Recall Z-0817-2016— Nihon Kohden America Inc

Name: FDA recall Z-0817-2016
Creator: U.S. Food and Drug Administration
Published: 2012-01-19

Class II · Terminated

Class II FDA medical device recall by Nihon Kohden America Inc, initiated 2012-01-19, terminated 2016-02-22. It names one FDA 510(k) clearance: K051178. Product: MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG). Reason: 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..

Recalling firm: Nihon Kohden America Inc
Classification: Class II
Status: Terminated
Initiated: 2012-01-19
Terminated: 2016-02-22
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K051178 — MEE-1000A NEUROMASTERNihon Kohden America, Inc.·cleared 2005-08-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.