Events

Retiro De Equipo (Recall) de Device Recall Integra InterFix CT Adapter (CTA)

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Integra LifeSciences Corp.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    61131
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1187-2012
  • Fecha de inicio del evento
    2012-01-23
  • Fecha de publicación del evento
    2012-03-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107363
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Accelerator, linear, medical - Product Code IYE
  • Causa
    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.
  • Acción
    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)
  • Modelo / Serial
    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
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including DC, IN, FL, HI, LA, NY, MD, MI, OH,OR, WI, WY, Foreign: Great Britain, Italy, and France
  • Descripción del producto
    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