Events

Rappel de Device Recall Powerheart AED, G2

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 Cardiac Science Corporation.

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
    59301
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2917-2011
  • Date de mise en oeuvre de l'événement
    2011-06-29
  • Date de publication de l'événement
    2011-08-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102212
  • 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
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Cause
    Cardiac science corporation (csc) intent to end service support and discontinue accessory sales of powerheart g2 automated external defibrillators. customers are recommended to choose a replacement aed prior to the current aed displaying any "service required" self test messages.
  • Action
    Cardiac Science Corporation (CSC) sent two "9200 SERIES CARDIAC SCIENCE AED NOTICE" letters dated August 2010 and March 2011 to all affected customers. The letters identifies the product, problem, and actions to be taken by the customers. Customers are encouraged to upgrade their devices through special offers by calling CSC at 800-426-0337, Option 2. For questions about the end of factory support for the affected devices, call the Technical Support team at 800-426-0337, Option 1. *****In August 2011, Cardiac Science sent out another updated recall notification letter to their consignees. This letter stated that once a device has entered the "Service Required" state, please contact the firm at 800.426.0337 Option 2. Per prior notifications, the 9200 series AEDs have reached the end of service life and can no longer be repaired. Information about these notifications may be found as an announcement in the Services and Support section of Cardiac Science website. Cardiac Science advised the customers to upgrade to a Powerheart AED G3 (this device supports the 2010 AHA/ERC Guidelines). It is strongly recommended that customer to choose a replacement AED prior to the current AED displaying any "Service Required" self test messages. For information about special offers to help you upgrade please call 800.426.0337. Option 2.

Device

Device Recall Powerheart AED, G2
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of AE, AT, AU, AW, BE, BR, CA, CH, CL, CN, CO, CY, CZ, DE, OK, EG, ES, FI, FR, GB, HK, HR, HU, 10, IE, IL, IN, IR, IS, IT, JP, KR, KW, KY, LB, LT, LV, MT, MX, NG, NL, NO, NZ, PE, PF, PL, PR, PT, QA, RO, RU, SA, SG, SK, SY, TH, TR, TT, TW, VG, ZA, and ZW.
  • Description du dispositif
    Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN, 9200RD, 9210N, 9210RD, and CardioVive 92530. || The battery component is warranted for 5 years, and electrodes have a shelf life of 2 years. || The Powerheart AED G2 and CardioVive 92530 are intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province, or country regulations in which they practice.
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

Cardiac Science Corporation
  • Adresse du fabricant
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • Société-mère du fabricant (2017)
    Cardiac Science Corporation
  • Source
    USFDA