Events

Rappel de BrightView X/XCT/XCT Upgrade 882480: BrightView (version 1.2.3 or 1.2.4)882478: BrightView X (version 2.5.3 or 2.5.4)882482: BrightView XCT (version 2.5.3 or 2.5.4)882454: BrightView XCT Upgrade (version 2.5.3 or 2.5.4)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia 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-00051-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-01-18
  • 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-00051-1
  • 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
    Philips have identified 4 issues with the brightview systems:1. during a cardiac non-auto body contouring (abc) scan, using cardiac high resolution (chr) collimators, the collimator may come in contact with the bottom edge of the patient pallet. if this occurs, collision sensors would pause the scan. although unlikely, if the collision sensors malfunction & the operator fails to activate the e-stop, this could lead to serious bodily injury for the patient.2. during a scan, the gantry motion may halt prematurely. this causes the scan sequence to pause.3. operator will receive a warning message that the scan may not complete & re-mark the points used to define the orbit when defined with a detector relative angle of 90 & head first supine/feet first prone setting. 4. resolved defects section of user release document 1.2.4/2.5.4 for brightview, brightview x & xct listed 2 pre-programmed motions (ppms) whose motion sequences were changed by the release of s/w v1.2.4/ 2.5.4.
  • Action
    The sponsor will provide a system software upgrade to correct the reported issues.

Device

BrightView X/XCT/XCT Upgrade 882480: BrightView (version 1.2.3 or 1.2.4)882478: BrightView X (ver...
  • Modèle / numéro de série
    BrightView X/XCT/XCT Upgrade 882480: BrightView (version 1.2.3 or 1.2.4)882478: BrightView X (version 2.5.3 or 2.5.4)882482: BrightView XCT (version 2.5.3 or 2.5.4)882454: BrightView XCT Upgrade (version 2.5.3 or 2.5.4)ARTG Numbers: 117642 and 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA