Rappel de Device Recall Airo

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 Mobius Imaging, LLC.

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
    69993
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1016-2015
  • Date de mise en oeuvre de l'événement
    2014-12-08
  • Date de publication de l'événement
    2015-01-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2015-07-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    System, x-ray, tomography, computed - Product Code JAK
  • Cause
    There is a risk that during the transfer of an image and navigation data to the brainlab curve image guided surgery navigation system after a ct scan, an error may occur, causing either no navigation data or incorrect navigation data being transferred to the curve.
  • Action
    Mobius sent an Urgent Field Safety Notice dated December 8, 2014, to all affected customers. The letter explains the recall and provides advise on action to be taken by the user. The letter also informs consignees that Mobius Imaging is working on a software fix for the software bug/communication error. The final fix is anticipated in early 2015. Advise on action to be taken by the user: The user should be prepared for the potential necessity to perform a manual navigation registration in order to use navigation. In general, do not use navigation data transmitted by the AIRO Mobile CT Scanner of any scan the Brainlab AIR App displayed the "Received Wrong Dataset" error for. To use such scans with the Curve, a manual navigation registration is required. To avoid the possibility of incorrect data from being transferred to the Curve, Mobius Imaging is recommending that customers only select "NO" when they come to the "Continue with same patient" screen after each scan. They can select the same patient under the "Existing Patients" tab and restart the workflow. Additionally, always adequately verify the accuracy of the navigation registration data as required by the Brainlab Curve" Navigation system software and the AERO Operator's Manual. If you require further clarification, please feel free to contact your local Brain lab Customer Support Representative. Customer Hotline: +49 89 99 15 68 44 or +1800 597 5911 (for US customers) or by E-mail: support@brainlab.com (for US customers: us.support@brainlab.com) Fax Brainlab AG: + 49 89 99 15 68 33 Address: Brainlab AG (headquarters), Kapellenstrasse 12, 85622 Feldkirchen, Germany. For questions regarding this recall call 978-615-5025.

Device

  • Modèle / numéro de série
    Serial #s: 2251 (#1)*, 2324 (#2), 2328(#3), 2344 (#4), 2346 (#5), AIRO-0106, AIRO-0107*, AIRO-0108, AIRO-0110, AIRO-0111, AIRO-0112, AIRO-0113, AIRO-0114, AIRO-0115, AIRO-0116, AIRO-0117, AIRO-0118, AIRO-0119, AIRO-0120, AIRO-0122, and AIRO-0123. *Demo system
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA including AK, IL, WA, MA, NY, WV, NC, TX, CA, PA and Internationally to Germany, Netherlands, Belgium, Switzerland, Saudi Arabia, Egypt.
  • Description du dispositif
    Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Mobius Imaging, LLC, 323 W Main St, Ayer MA 01432-1239
  • Société-mère du fabricant (2017)
  • Source
    USFDA