MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)
FDA Recall Z-0817-2016 · Posted 2016-02-17
Recalling FirmNihon Kohden America Inc
Recall StatusTerminated
Product CodeGWF
Date Initiated2012-01-19
Date Terminated2016-02-22
Product Quantity477 units total (137 units in US)
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution. US nationwide, Australia, Austria, France, Germany, Greece, Japan, Romania, South Africa, South Korea, Spain, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.