Events

Rappel de Vermed, Inc Radiotransparent Defibrillation Electrodes

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 Heart Sync, 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
    65085
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1435-2013
  • Date de mise en oeuvre de l'événement
    2013-04-26
  • Date de publication de l'événement
    2013-05-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118238
  • 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
    Electrode, pacemaker, temporary - Product Code LDF
  • Cause
    On 4/18/13 heartsync became aware of a recall from their wire/connector sub-assembly supplier which is used in the c100-physio electrodes. there were reports of equipment damage due to misalignment from tooling installed in august 2012. the result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.
  • Action
    HeartSync sent an URGENT MEDICAL DEVICE RECALL notification letter dated April 26, 2013, to all consignees of Heart Sync for C100-Physio Radiotransparent Defrillation Electrodes. On April 29, 2013, an URGENT MEDICAL DEVICE RECALL notification was sent to Vermed Inc for the D304 Defrillation Electrodes . The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the affected product to the firm for full credit. Customers were asked to complete the form and send back via fax to 734-213-5640 or call 734-213-5530. For questions regarding this recall call 734-213-5530. .

Device

Vermed, Inc Radiotransparent Defibrillation Electrodes
  • Modèle / numéro de série
    Part Number: D304 and lot numbers:Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea.
  • Description du dispositif
    Vermed, Inc Radiotransparent Defibrillation Electrodes || Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. || Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.
  • Manufacturer
    Heart Sync, Inc

Manufacturer

Heart Sync, Inc
  • Adresse du fabricant
    Heart Sync, Inc, 5643 Plymouth Rd, Ann Arbor MI 48105-9586
  • Société-mère du fabricant (2017)
    Heart Sync, Inc
  • Source
    USFDA