Events

Rappel de Nicolet Elite Doppler Probe 2 MHz and 3 MHz Obstetric, 5 MHz Vascular

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Swirl Technologies Pty Ltd T/A Parker Healthcare.

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-2017-RN-00845-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-14
  • 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-2017-RN-00845-1
  • 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
    The manufacturer has advised that some devices have excessive background noise. this has been determined to be caused by an issue with the transistor circuit.
  • Action
    Complete the supplied Verification Facsimile/Email Reply Form and then return it as directed to Parker. If any of the investigated products have been transferred to another facility, please immediately let that facility know of this Recall for Product Correction, and record it on the Verification Facsimile/Email Reply Form. If the excessive noise is suspected to be present, or you have any Technical inquiry, please contact Parker Healthcare Service Department as directed. These units will be returned to the Manufacturer in the USA for product correction.

Device

Nicolet Elite Doppler Probe 2 MHz and 3 MHz Obstetric, 5 MHz Vascular
  • Modèle / numéro de série
    Nicolet Elite Doppler Probe 2 MHz and 3 MHz Obstetric, 5 MHz Vascular ARTG Number: 128657 (Swirl Technologies Pty Ltd T/A Parker Healthcare - Ultrasound system, non-imaging, Doppler blood-flow measurement)Serial Number(s):Model: 3 MHz ObstetricSerial Number: CAQ0472
  • Manufacturer
    Swirl Technologies Pty Ltd T/A Parker Healthcare

Manufacturer

Swirl Technologies Pty Ltd T/A Parker Healthcare
  • Source
    DHTGA