Events

Rappel de Philips Briiliance (BR) CT 16-Slice, BR CT 10-Slice Water, BR CT 6-Slice Water, MX8000 Quad, MX8000 Dual, MX8000 Dual EXP, MX8000 IDT and MX8000 IDT 10

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Philips Medical Systems (USA).

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
    15027
  • Date de mise en oeuvre de l'événement
    2013-07-19
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Cause
    The ct system phantom supplied with the above-listed scanners has a special pin by which the customer can check the low contract (lc) detectability for quality assurance. this pinconsists of a nylon (aculon) body with six smaller lexan pins of 3mm, 4mm, 5mm, 6mm, 7mm and 8mm diameters, which have contrast difference of approximately 1% from aculon., the lc test is performed by visually inspecting the sectionand selecting the smallest detectable lexan pin for a predefined scan protocol as defined in the instructions for use. the manufacturer-recommended procedure is subjective in nature and needs to be performed on several scans and by different people to be reliable., the pin visibility deteriorates over time because of slow water absorption. as the pin visibility deteriorates the test becomes unreliable and inaccurate.
  • Action
    Instructions for use to be updated

Device

Philips Briiliance (BR) CT 16-Slice, BR CT 10-Slice Water, BR CT 6-Slice Water, MX8000 Quad, MX80...

Manufacturer

Philips Medical Systems (USA)
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NZMMDSA