Events

Rappel de Device Recall Integra InterFix CT Adapter (CTA)

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 Integra LifeSciences Corp.

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
    61131
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1187-2012
  • Date de mise en oeuvre de l'événement
    2012-01-23
  • Date de publication de l'événement
    2012-03-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107363
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Cause
    Material used in the superior region of the interfix ct adapter (cta) has a different density than that of the treatment table couch adapter (tta). resulting dosimetry can be affected if posterior fields are used. integra estimates that a target dose decrease of 1.2% would result from a typical 360 degree tomotherapy arc.
  • Action
    Integra sent a Product Technical Bulletin dated January 23, 2012, to all affected consignees via FedEx, email or telephone conference calls. The revised Operator Manual was provided with a Technical Bulletin to all consignees that have been shipped this system. Consignees were asked to distribute the information in the bulletin to members of the Radiotherapy Planning Team within their institution. Customers were also asked to sign and return the enclosed Product Technical Bulletin Acknowledgement Form. For questions regarding this recall call 888-772-7378.

Device

Device Recall Integra InterFix CT Adapter (CTA)
  • Modèle / numéro de série
    Lot Number: 113820 114121 114430 114586 117771 121402 130169 131122 133760 133810 135008 135429 135429 141074 141563 143905 143905 148028 154133 155785 161426 166069 168862 172321 172321 182007 186253 189940 195330 195330 237711 2 units no lot number identified
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including DC, IN, FL, HI, LA, NY, MD, MI, OH,OR, WI, WY, Foreign: Great Britain, Italy, and France
  • Description du dispositif
    Integra InterFix CT Adapter (CTA) || Intended for cranial fixation during CT scanning and || treatment with the TomoTherapy HiArt (Torno) System || The Integra InterFix CT Adapter (CTA) kits are intended for cranial fixation during CT and and treatment with the Tomo Therapy Hi-Art system. Provides adapters for attaching: Integra head rings to the following: 1.Flat CT scanner tabletops ranging form 47cm to 54 cm 2. TomoTherapy Hi-Art system tabletop
  • Manufacturer
    Integra LifeSciences Corp

Manufacturer

Integra LifeSciences Corp