CLASS II Device recall · Reported 24 Feb 2016 · FDA Enforcement Report

MEE-1000A Neuromaster recalled by Nihon Kohden America

Nihon Kohden America is recalling MEE-1000A Neuromaster, distributed nationwide in the US. The recall was initiated on 19 Jan 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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, 00039, 00043, 00102,00103, 00122-00128, 00134, 00135 JB-132B: (83 units) 00009, 00011, 00012, 00014, 00015, 00016, 00018, 00019, 00020, 00021, 00023, 00024, 00025, 00026, 00027, 00036, 00037, 00038, 00041, 00042, 00043, 00044, 00046, 00047, 00049, 00061, 00062, 00066, 00067, 00068, 00069,00071, 00072, 00074, 00075, 00082, 00084, 0085, 00086, 00090, 00095, 00099, 00120, 00121-00129, 00131-00147, 00149-00155, 00157, 00161, 00164-00168

Quantity recalled477 units total (137 units in US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0817-2016
FDA event ID: 73114
Recalling firm: Nihon Kohden America, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 19 Jan 2012
FDA classified: 17 Feb 2016
Reported: 24 Feb 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

19 Jan 2012	Recall initiated by company
17 Feb 2016	Classified by FDA	+1490 days
24 Feb 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution. US nationwide, Australia, Austria, France, Germany, Greece, Japan, Romania, South Africa, South Korea, Spain, and United Kingdom.

Nationwide

Questions about this recall

Is MEE-1000A Neuromaster recalled?

Yes. Nihon Kohden America recalled MEE-1000A Neuromaster on 19 Jan 2012. The recall is Class II and its status is Terminated. Recall number Z-0817-2016.

Why was it recalled?

Which lots are affected?

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, 00039, 00043, 00102,00103, 00122-00128, 00134, 00135 JB-132B: (83 units) 00009, 00011, 00012, 00014, 00015, 00016, 00018, 00019, 00020, 00021, 00023, 00024, 00025, 00026, 00027, 00036, 00037, 00038, 00041, 00042, 00043, 00044, 00046, 00047, 00049, 00061, 00062, 00066, 00067, 00068, 00069,00071, 00072, 00074, 00075, 00082, 00084, 0085, 00086, 00090, 00095, 00099, 00120, 00121-00129, 00131-00147, 00149-00155, 00157, 00161, 00164-00168

Where was it sold?

Worldwide distribution. US nationwide, Australia, Austria, France, Germany, Greece, Japan, Romania, South Africa, South Korea, Spain, and United Kingdom.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Nihon Kohden America

All 10

Reported	Class	Recall	Company	Reason	Where
13 Nov 2024Device	CLASS II	Adult Cap-ONE Biteblock recalled by Nihon Kohden America	Nihon Kohden America	Other	Nationwide
6 Nov 2024Device	CLASS II	Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 9m recalled	Nihon Kohden America	Device Malfunction	29 states
6 Nov 2024Device	CLASS II	Nihon Kohden Adult Ear Clip SpO2 Sensor, 5 meter recalled	Nihon Kohden America	Device Malfunction	29 states
12 Jun 2024Device	CLASS II	BSM-3000 Series Bedside Monitor recalled by Nihon Kohden America	Nihon Kohden America	Device Malfunction	Nationwide
10 Mar 2021Device	CLASS II	WMTS Telemetry Receiver, Multiple Patient Receiver recalled	Nihon Kohden America	Other	46 states

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide