Events

Rappel de Device Recall 43410 FRAMELESS SRS QA TARGET POINTER

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 Brainlab AG.

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
    65773
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2083-2013
  • Date de mise en oeuvre de l'événement
    2013-07-16
  • Date de publication de l'événement
    2013-08-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120110
  • 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
    The frameless srs qa target pointer - pointer cap with the engraved cross hairs may become loose even when only a moderate force is applied to the pointer cap.
  • Action
    BrainLab sent an "FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" dated July 9, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to discontinue use of the SRS QA Target Pointer. Consignees can instead use the Phantom Pointer feature until Brainlab can provide replacement hardware. Brainlab anticipates being able to provide all impacted facilities with replacement hardware by the end of July 2013. We sincerely apologize for any inconvenience and thank you in advance for your co-operation. If you require further clarification, please feel free to contact your local Brainlab Customer Support Representative. Customer Hotline: +49 89 99 15 68 44 or +1 800 597 5911 (for US customers) or by E-mail: support@brainlab.com. Fax Brainlab AG: + 49 89 99 15 68 33

Device

Device Recall 43410 FRAMELESS SRS QA TARGET POINTER
  • Modèle / numéro de série
    Part No. 43410
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution only to AR., and the countries of Australia, Germany and Japan.
  • Description du dispositif
    BRAINLAB; FRAMELESS SRS QA TARGET POINTER || Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's: head and neck; and head, neck, and shoulders, in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG
  • Adresse du fabricant
    Brainlab AG, Kapellenstrasse 12, Feldkirchen Germany
  • Société-mère du fabricant (2017)
    Brainlab AG
  • Source
    USFDA