Events

Rappel de EP4 Computerized Stimulator

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 EP Medsystems.

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
    35206
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0914-06
  • Date de mise en oeuvre de l'événement
    2006-04-04
  • Date de publication de l'événement
    2006-05-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-04-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45507
  • 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 - Product Code JOQ
  • Cause
    Under certain circumstances the device may exhibit the following behaviors: 1)-initiation of a rapid stimulation train without command, when the device is in use in conjuction with an electrosurgical unit or rf ablation unit-2)-presence of a dc offset voltage on an output channel-3)-inability to synchronize with a non-ep medsystems recording system.
  • Action
    The firm initiated the recall on April 4, 2006 through a notification letter sent to the electrophysiology lab managers at the healthcare institutions and two domestic distributors to which the device has been distributed. The firm used a traceable courier service to deliver notification of the recall.

Device

EP4 Computerized Stimulator
  • Modèle / numéro de série
    Model number: EP-4-02 and EP-4-04.  EP40312-001 through 010; EP40403-001 through 014; EP40406-001 through 042; EP40408-001 through 039; EP40410-001 through 040; EP40411-001 thourgh 040; EP40504-001 through 040; EP40506-001 through 040; EP40508-001 through 020; EP40510-001 through 020; EP40511-001 through 040.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was shipped to hospitals/users throughout the US. The firm has a Veterans Affair contract number V797P-4650A. Also the firm has shipped the devices to Germany, United Kingdom, Netherlands, Italy, Japan, France, Saudi Arabia, Hong Kong, Syria, Malaysia, Sweden, Armenia, Australia, Canada, Iceland, S. Africa, and Taiwan.
  • Description du dispositif
    EP-4 Computerized Stimulator -- 2 channel and 4 channel. The product consists of a touchscreen portable PC controlling a two channel dedicated EP stimulator. The stimulator is capable of single channel, simultaneous and sequential stimulation at programmed output settings using built-in protocols, and includes an emergency stimulation function.
  • Manufacturer
    EP Medsystems

Manufacturer

EP Medsystems
  • Adresse du fabricant
    EP Medsystems, 575 Route 73 North, Bldg D, Cooper Run Executive Park, West Berlin NJ 08091
  • Source
    USFDA