Events

Rappel de Device Recall Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2

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 Elekta, 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
    57688
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1555-2011
  • Date de mise en oeuvre de l'événement
    2007-08-23
  • Date de publication de l'événement
    2011-03-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97006
  • 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
    Under certain conditions it has been found that movement of the collimators can be induced during multi segment beams such as imrt and omniwedge which will not be detected by the desktop pro if high values are sent within the icom tolerance table.
  • Action
    The firm, Elekta, sent an "Important Notice A302" dated August 23, 2007 titled "Update to iCom Tables for Desktop Pro when used with Third Party R&V; Systems",to all affected customers. On September 28, 2007, Elekta issued a second Important Notice A304 which reiterated the same information as was in Important Notice A302. The notices described the product, problem and actions to be taken. This notice provides a workaround on how to avoid the issue. In order to avoid this issues documented, Elekta recommended that the customers set the tolerance for collimators in the iCom tolerance table to be 3.0 degrees-no less than 3.0 and to use the Linac Record, if configured, as a means of checking the final collimator position. Elekta noted that the issue will be resolved in a future release of Desktop Pro. If you any questions related to this issue, please contact your local Elekta, third party R&V; system representative or Elekta Limited at +44 (0)1293 654200.

Device

Device Recall Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2
  • Modèle / numéro de série
    134615, 134621, 134091, 136364, 134172, 136285, 134605, 134183, 136167, 136234, 134259, 134115, 134081, 136047, 136063, 134701, 134328, 134391, 134432, 134436, 134438, 136119, 134535, 134561, 134475, 134564, 134154, 134269, 134348, 134399, 136084, 136087, 136100, 134200, 134118, 134822, 134018, 136368, 134241, 134606, 134711, 134473, 134787, 134768, 134571, 134237, 134104, 136009, 134331, 134272, 136322, 136175, 136200, 134503, 136257, 134322, 134781, 134380, 134709, 136108, 134250, 134254, 134258, 134206, 134195, 134094, 134652, 134704, 136107, 134469, 134472, 134483, 134519, 134729, 136109, 134236, 134239, 134197, 134456, 134047, 134092, 134211, 136373, 134275, 134679, 136106, 136163, 134667, 136181, 134169, 134329, 134126, 134090, 134358, 134427, 134626, 134819, 134027, 134265, 134597, 136319, 134220, 134256, 134396, 134804, 134235, 136338, 134137, 134234, 134249, 136034, 136065, 136110, 136267, 136291, 134213, 134219, 136330, 134750, 136097, 136270, 134457, 134078, 134129, 136195, 134375, 134603, 136074, 134075, 134565, 134196, 134428, 134430, 134008, 134382, 134070, 134157, 134772, 136080, 134860, 134401, 134368, 134388, 134631, 134318, 136015, 136096, 134563, 136165, 136240, 134441, 134017, 134048, 134189, 134395, 134324, 134595, 134140, 134212, 136086, 134354, 136178, 136317, 136318, 134445, 136012, 136332, 134321, 136071, 136089, 136292, 136293, 134673, 134685, 136059, 136169, 134073, 134748, 134754, 134378, 134383, 134458, 134192, 134499, 136069, 136092, 134642, 134295, 134671, 136046, 136147, 134062, 136049, 136036, 136152, 136157, 136083, 136081, 134770, 136118, 136156, 136172, 134352, 134548, 134533, 136153, 136269, 136197, 136252, 136286, 136315, 136241, 134811, 134812, 136258, 136312, 134069, 136310, 134864, 134040, 134046, 134307
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including Puerto Rico and countries including: Canada and Mexico.
  • Description du dispositif
    Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2 || A user interface of rthe SL/SLi Series Linear Accelerators that are used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Adresse du fabricant
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    USFDA