Events

Rappel de Device Recall Varian brand ARIA Radiation Oncology

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 Varian Medical Systems, Inc. Oncology Systems.

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
    63713
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0531-2013
  • Date de mise en oeuvre de l'événement
    2012-11-05
  • Date de publication de l'événement
    2012-12-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-03-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114598
  • 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
    Varian medical systems has identified an anomaly with the aria oncology information system radiation oncology [aria ro] dicom import/export functionality where a 360 degree arc field may convert to static field during dicom export or import.
  • Action
    Varian sent an Urgent Medical Device Correction Urgent Field Safety Notice dated November 6, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that the plan was not converted unintentionally during import/export. Customers would be contacted by a Customer Service Representative when the correction was available to schedule installation on their system. Customers with questions were instructed to contact their local Varian Medical Systems Customer Support District or Regional Manager. US and Canada 1-888-827-4265. For questions regarding this recall call 650-424-5731.

Device

Device Recall Varian brand ARIA Radiation Oncology
  • Modèle / numéro de série
    CODES:  HITOO28, HIT0963, HITl780, HIT242S, HIT4118RI, HIT0632M, HITIS87R4, HIT2208RS, HID088R6, HITOO32, HIT0983M, HITl800, HIT2434, HIT4263, HlT0632Rl, HlTlS89M, HIT2212, HIT3097, HITOO49M, HIT0983RI, HITI8S4, HIT244I, HIT438I, HIT0632R2, HITlS89Rl, HlT2237M, HIT316S, HITOl16M, HIT0983R2, HITl874, HIT2477M, HIT4439RI, HIT0668, HITIS89R2, HlT2237RI, HIT3206, HITOI16RI, HIT0998, HITl898, HIT2477RI, HIT4SSS, HIT0691M, HITIS89R3, HIT2267M, HIT3267, HIT0134, HITI036, HITl9S8, HlT2477R2, HIT4S92, HIT0691RI, HlTlS89R4, HlT2267RI, HIT3268, HITOISS, HITl119M, HITl968, HIT2477R3, HIT4627, HIT0691R2, HITlS89RS, HIT227SM, HIT3308, HITOI70M, HITII19RI, HIT2037M, HIT2SI2M, HIT477I, HIT0691R3, HITlS89R6, HIT227SRI, HIT3438M, HITOI70RI, HITI139, HIT2037RI, HIT2SI2RI, HlT4800, HIT0764, HITlS89R7, HIT227SR2, HIT3S13, HITOI70R2, HITll49M, HIT2037RII, HIT2S22, HIT4884, HIT0816, HITIS89R8, HlT227SR3, HIT3679, HITOI70R3, HITll49Rl, HIT2037R12, HlT2S46, HIT4888M, HIT0828, HITIS89R9, HIT227SR4, HIT3764RI, HlTOl82, HITI184Al, HIT2037RI3, HIT2S63M, HIT4888RI, HIT08S2, HITI622, HlT2291M, HlT377S, HITOl83, HlTll84M, HIT2037R14, HIT2S63RI, HIT4888R2, HIT090lM, HITI660M, HIT229IRI, HlT3796, HITOl91M, HITll84RI, HIT2037RIS, HIT2S63R2, HIT4888R3, HIT090lRI, HlTl660R2, HIT2291R2, HID910, HITOl91RI, HITI229, HIT2037R16, HIT2S63R3, HIT4894, HIT0926, HITl660R3, HlT2291R3, HIT3927M, HITOI91R2, HITI277, HIT2037R17, HIT2S63R4, HIT4896, HIT0933M, HlTI671, HIT2291R4, HlT3927RI, HIT0227, HITl363M, HlT2037R2, HIT2S91, HIT4903, HIT0933RI, HITl693, HIT229IRS, HlT3927R2, HIT0337M, HITl363RI, HlT2037R3, HIT26IS, HlT4906, HIT0933R2, HITl726, HIT2291R6, HIT394S, HIT0337RI, HITl4I2, HlT2037R4, HIT2643, HIT4909, HIT0933R3, HITl7S7, HlT2293, HlT3967, HIT0337R2, HITl430M, HIT2037RS, HlT264S, HlT4932M, HIT0933R4, HITl764M, HIT2336M, HIT4014, HIT0337R3, HITl430RI, HIT2037R6, HIT2834, HIT4932RI, HIT0933RS, HITI764RI, HIT2336RI, HIT4107, HIT0339M, HITI430R2, HIT2037R7, HIT286S, HIT4938, HIT0933R6, HITl767M, HIT2346M, HIT41l6, HIT0339RI, HITl430R3, HIT2037R8, HIT2894M, HIT4942M, HIT0933R7, HITI767RI, HIT2346RI, HIT41I8M, HIT0341M, HITI470M, HIT2037R9, HIT2894Rl, HIT4942RI, HIT0341RI, HITl470RI, HIT2067, HIT2894R2, HIT4947, HIT0342, HITl470R2, HIT209S, HIT2894R3, HIT4974, HIT0383, HITI498, HIT2102, HlT2943, HIT4975, HIT0397, HITlSI4, HIT2140, HlT29S3, HIT4982, HIT0432M, HITlS23M, HIT2I80, HIT2997, HITSOII, HIT0432RI, HITlS23RI, HIT2188, HIT3088M, HITS048, HIT0432R2, HITIS7S, HIT2208M, HIT3088RI, HITS061, HIT0468M, HITlS87M, HIT2208Rl, HIT3088R2, HITS088, HIT0468RI, HlTlS87RI, HIT2208R2, HIT3088R3, HITS089, HITOS3S, HlTlS87R2, HIT2208R3, HIT3088R4, HITSI16, HITOSSI, HITIS87R3, HIT2208R4, HIT3088R5, HITSl41
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; || Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • Adresse du fabricant
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Société-mère du fabricant (2017)
    Varian Medical Systems Inc
  • Source
    USFDA