Events

Rappel de Medtronic O-Arm O2 Surgical Imaging System (a portable, diagnostic, fluoroscopic x-ray system)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtronic Australasia Pty Ltd.

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
    RC-2016-RN-00966-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-20
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00966-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    After investigation of complaints, medtronic has determined that the o-arm o2 system requires updates. 1. certain aspects of the technical information in the instructions for use document require clarification. the information to be updated includes the system’s specification for x-ray filtration strength, leakage technique factors, tube housing cooling curves, technique factor measuring criteria, and air kerma reference location.2. radiation measurement methodologies associated with confirming the accuracy specifications of the air kerma displays do not fully comply with requirements.3. the x-ray technique factor display accuracy related to ma might not be compliant to the system specifications.Please note that items 1 and 2 do not affect the safety or performance of the system. item 3 does not increase the safety risk of the product to users or patients, but could affect performance related to image quality.
  • Action
    Medtronic is providing users with updated errata sheets with updated the correct information and following this up with an update to the system software that corrects this information in the on-system Instructions for Use. In addition, Medtronic will be performing the appropriate measurements of air kerma rate, as well as testing the x-ray technique factor display accuracy for compliance.

Device

Medtronic O-Arm O2 Surgical Imaging System (a portable, diagnostic, fluoroscopic x-ray system)
  • Modèle / numéro de série
    Medtronic O-Arm O2 Surgical Imaging System (a portable, diagnostic, fluoroscopic x-ray system)Model Numbers: B1-700-00027, BI-700-00028ARTG Number: 135566
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA