Events

Rappel de ElectriCord

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 GE Medical Systems Information Technologies.

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
    26293
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0011-04
  • Date de mise en oeuvre de l'événement
    2003-04-30
  • Date de publication de l'événement
    2003-10-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27445
  • 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
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) - Product Code MWI
  • Cause
    Reports of broken plug ground pins on ac power cords for patient monitors.
  • Action
    The recalling firm mailed a Recall Notification Letter with response form and corretive power cords beginning on April 30, 2003 until August 14, 2003 as corrective cords became available. Consignees were instructed on how to determine if they have the recalled cords and to destroy any found by cutting the plug from the wire. Also corrective AC power cords were provided to each consignee.

Device

ElectriCord
  • Modèle / numéro de série
    Lot numbers 01-08 through 02-16 which are embossed into the power cord metal blades and also those with no lot numbers.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The recalled AC power cords were distributed to approximately 2600 Domestic hospital accounts nationwide and 180 international accounts.
  • Description du dispositif
    Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.
  • Manufacturer
    GE Medical Systems Information Technologies

Manufacturer

GE Medical Systems Information Technologies
  • Adresse du fabricant
    GE Medical Systems Information Technologies, 4502 Woodland Corporate Blvd., Tampa FL 33614
  • Source
    USFDA