Events

Rappel de Device Recall PET511BTM Multiplane transesophageal transducer (TEE)

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 Toshiba American Medical Systems 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
    53892
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1100-2010
  • Date de mise en oeuvre de l'événement
    2009-05-11
  • Date de publication de l'événement
    2010-03-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86818
  • 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
    Ultrasonic pulsed echo imaging system - Product Code IYO
  • Cause
    Toshiba america medical systems inc is removing the pet-511btm multi-plane transesophageal transducer from the market after receiving several reports of injury regarding the transducer. bending or buckling of the flexible portion of the pet-511 btm multi-plane transesophageal transducer (tee) may result in injury including perforation.
  • Action
    Toshiba America Medical Systems sent a Field Safety Notice to all customers on 5 MAY 2009 indicating its intent to remove the units from the market. The letter requested immediate cessation of use and return to the manufacturer site. It announced plans to replace unit with a new multi-plane transducer at no addle charge. The notice also included a description of the problem that occurred, the proper insertion technique into the esophageal passage, how to avoid and detect bending or buckling of the transducer, and what to do if the transducer does buckle. A revised safety manual and poster reflecting these precautions for the PET-51 IBTM was sent to each customer using this transducer. Shipments of the transducer from December 2008 also contained the Field Safety Notification materials. For additional information, contact the firm at (714) 669 2458.

Device

Device Recall PET511BTM Multiplane transesophageal transducer (TEE)
  • Modèle / numéro de série
    All units
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    PET-511BTM Multi-plane transesophageal transducer (TEE) used with Toshiba Diagnostic Ultrasound System
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Adresse du fabricant
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Société-mère du fabricant (2017)
    Canon Inc
  • Source
    USFDA