Events

Rappel de Device Recall Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science).

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
    51812
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1757-2010
  • Date de mise en oeuvre de l'événement
    2009-03-30
  • Date de publication de l'événement
    2010-06-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81323
  • 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
    stress treadmill - Product Code IOL
  • Cause
    28 stress and rehab treadmills manufactured between september 2006 and january 2009 may not have received adequate electrical safety testing prior to being shipped from the factory. if these components break down in the field, a patient or operator could be exposed to excess touch currents on the surface of the product. because safety testing may not have allowed for complete evaluation of the el.
  • Action
    On April 3, 2009 the recalling firms notified consignees by certified letter to domestic customers and via FedEx to international customers with delivery confirmation signature required. Customers were advised to remove treadmill from service until it is tested by a Field Service Engineer. For customers with questions or those that have not already scheduled a service call with Cardiac Science Field Service Engineers, please contact the firm at 1.800.426.0337, option 1.

Device

Device Recall Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and C...
  • Modèle / numéro de série
    Lot/Serial Numbers: 11040077414 ,11040077801 ,11040077859 ,11040077861 ,11040077969 ,11040077977 ,11040077974 ,11040078366 ,11040078367 ,11040078375 ,11040078376 ,11040078379 ,11040078385 ,11040078384 ,11040078368 ,11040078395 ,11040078452 ,11040078891 ,11040079014 ,11040079161 ,11040079568 ,11040079567 ,11040079569 ,11040079671 ,11040079734 ,11040079939 ,11040079880 ,11040080124
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distributed domestically (including Puerto Rico) to 20 end-user accounts and 2 distributor accounts; Distributed internationally to: Canada, Mexico, Portugal, and Saudi Arabia.
  • Description du dispositif
    Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science).
  • 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