Events

Retiro De Equipo (Recall) de O-Arm 1000 Surgical Imaging System (Portable, diagnostic, fluoroscopic x-ray system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic Australasia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-00965-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-20
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00965-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    After investigation of complaints, medtronic has determined that the o-arm 1000 system requires updates. 1.Technical information in the ifu require clarification, including specifications for x-ray technique factor accuracy, filtration strength, leakage technique factors, air kerma reference location, and tube housing cooling curves.2. radiation measurement methodologies associated with confirming the accuracy specifications of the air kerma displays do not fully comply.3. the x-ray technique factor display accuracy related to ma and mas do not comply.4. x-ray generator and motion batteries require inspection to insure they are not damaged.Items 1 & 2 do not affect the safety or performance of the system. item 3 could affect performance related to image quality. item 4 addresses possible shipping damage to the batteries. damaged batteries may result in odours/fumes, smoke, and the system not functioning as intended.
  • Acción
    Medtronic is providing users with updated errata sheets with 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. A visual and electrical inspection of the batteries will also be undertaken for any potential damage.

Device

O-Arm 1000 Surgical Imaging System (Portable, diagnostic, fluoroscopic x-ray system)
  • Modelo / Serial
    O-Arm 1000 Surgical Imaging System (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
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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