The Recall Desk
HighFDA (Devices)·Z-0817-2016·Announced 2016-02-24

Nihon Kohden MEE-1000A Neuromaster Accessories Recalled for Defective Circuit Boards

Nihon Kohden America Inc is recalling MEE-1000A Neuromaster accessories due to defective printed circuit boards that failed to prevent unintentional current flow.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (electrical shock) where injury has not yet been reported, fitting the 'High' severity criteria for medical devices with potential for harm but no confirmed adverse events.

Plain-English summary

Nihon Kohden America Inc is recalling specific accessories for the MEE-1000A Neuromaster, including the MS-110B Electric Stimulation, MS-120BK Current Stimulator Box, and JB-116B and JB-132B Amplifiers. The recall involves 477 units total, with 137 units distributed in the United States and the remainder distributed worldwide in Australia, Austria, France, Germany, Greece, Japan, Romania, South Africa, South Korea, Spain, and the United Kingdom.

The recall is due to defective printed circuit boards (PCBs) on the affected accessories. Gas arrestors on these boards, which are intended to provide protection from electrostatic discharge, failed to prohibit unintentional current flow. This defect poses a risk of electrical shock to patients or users.

Healthcare facilities and users should stop using the affected accessories immediately. Affected units can be identified by specific serial numbers listed in the recall notice. Users should contact Nihon Kohden America Inc for further instructions on repair or replacement.

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.