Events

Retiro De Equipo (Recall) de Rigid Arm Supports(used as part of Posiboard-2 and Positrest)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por alphaXRT 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-2017-RN-01031-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-08-09
  • 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-2017-RN-01031-1
  • 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
    The manufacturer civco radiotherapy have identified that specific units of rigid arm supports may have a height difference of approximately 17mm compared to those manufactured after july 2012.Due to the potential height variation in the rigid arm supports there is potential for mistreatment if there are multiple devices in the facility with varying heights between simulation and treatment. changes in arm position due to variation will impact the position of the chest wall and breast position. a 16.8mm variation in arm positioner could result in chest/breast/heart position changes which exceed expected treatment planning margins.
  • Acción
    alphaXRT is requesting Customers: 1. If your facility has an affected device and a newer device which is not included in the list, then usage should be immediately suspended; 2. Complete the supplied customer acknowledgment form and return it to NP@alphaXRT.com; 3. Retain a copy of the Customer Letter along with your most current product labelling; 4. Ensure relevant staff members are informed of this recall including relevant clinicians who may need to monitor for adverse events. 5. Place the notification letter in a prominent position for at least one month.

Device

Rigid Arm Supports(used as part of Posiboard-2 and Positrest)
  • Modelo / Serial
    Rigid Arm Supports(used as part of Posiboard-2 and Positrest)Reference Numbers: 106047, 106015Lot Numbers: M164340, M178170, M165430, M165440, M191710 and M192470ARTG Number: 149575
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    alphaXRT Pty Ltd

Manufacturer

alphaXRT Pty Ltd