Events

Rappel de Device Recall EP4 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 St. Jude Medical.

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
    51681
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1422-2009
  • Date de mise en oeuvre de l'événement
    2009-03-23
  • Date de publication de l'événement
    2009-06-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-01-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80957
  • 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
    External Programmable Pacemaker Pulse Generator - Product Code JOQ
  • Cause
    Non-compliance with iec standard 60601-1 clause 57.6 relative to fusing of ac input line. the neutral line is not fused. the hot line in fused. clause 57.6 calls for both lines to be fused.
  • Action
    All foreign customers were sent Urgent Product Safety Information letters on March 23, 2009. Letters described units affected, the reason for action, and the actions to take to eliminate risk. It is recommended that the information in the letter be circulated to all users, risk managers and the biomedical engineering department responsible for maintaining and inspecting electrical equipment located within their institution. The letter also stated that a SJM representative will be in touch to perform the EP-4 Stimulator fuse modification. Customers are to complete and return the attachment.

Device

Device Recall EP4 Stimulator
  • Modèle / numéro de série
    Systems Part Numbers: EP-4I-2-110; EP-4I-2-220; EP-4I-4-110; EP-4-220: WM-01M-241; WM-01M-560; WM-01M-1200; WM-02M-241; WM-02M-560; and WM-02M-1200.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution.
  • Description du dispositif
    EP-4 Computerized Cardiac Stimulator; SJM Part Numbers: 09-1527-0000 / 09-1527-0002; || EP MedSystems, Inc. || 575 Route 73 North, Units D, West Berlin, NJ 08091. || Indicated for use during clinical electrophysiology procedures.
  • Manufacturer
    St. Jude Medical

Manufacturer

St. Jude Medical
  • Adresse du fabricant
    St. Jude Medical, 575 Route 73 North, Bldg D, Cooper Run Executive Park, West Berlin NJ 08091
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA