Events

Rappel de Device Recall Accessories used with MEE1000A Neuromaster

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Nihon Kohden America Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    73114
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0817-2016
  • Date de mise en oeuvre de l'événement
    2012-01-19
  • Date de publication de l'événement
    2016-02-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-02-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143082
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Stimulator, electrical, evoked response - Product Code GWF
  • Cause
    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.
  • 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.

Device

Device Recall Accessories used with MEE1000A Neuromaster
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution. US nationwide, Australia, Austria, France, Germany, Greece, Japan, Romania, South Africa, South Korea, Spain, and United Kingdom.
  • Description du dispositif
    MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)
  • Manufacturer
    Nihon Kohden America Inc

Manufacturer

Nihon Kohden America Inc
  • Adresse du fabricant
    Nihon Kohden America Inc, 15353 Barranca Pkwy, Irvine CA 92618-2216
  • Société-mère du fabricant (2017)
    Nihon Kohden Corp.
  • Source
    USFDA