Events

Rappel de Device Recall Philips Ingenuity Core128/Elite China 728324

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems (Cleveland) Inc.

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
    80176
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2277-2018
  • Date de mise en oeuvre de l'événement
    2018-03-28
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164819
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    System, x-ray, tomography, computed - Product Code JAK
  • Cause
    A problem has been detected in the x-ray tube. the affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
  • Action
    Urgent Field Safety Notice letters were sent to customers on 3/28/18. The letters did not request any actions to be conducted by the customers. For Brilliance Big Bore/ Ingenuity CT / Ingenuity Core / Ingenuity Corel 28 Customers: A Philips Field Service Engineer will contact you to schedule the FCO updates at your site. Field Change Order (FCO 72800691 and 72800692) will be released to correct the issue. For Ingenuity TF PET/CT Customers: Field Change Order (FCO 88200520 and 88200511) will be released to correct this issue. A Philips Field Service Engineer will contact you to schedule the FCO updates at your site.

Device

Device Recall Philips Ingenuity Core128/Elite China 728324
  • Modèle / numéro de série
    UDI: (01)00884838059863(21)336856, Serial Number: 336856;  UDI: (01)00884838059863(21)336851, Serial Number: 336851;  UDI: (01)00884838059863(21)336849, Serial Number: 336849;  UDI: (01)00884838059863(21)336852, Serial Number: 336852; UDI: (01)00884838059863(21)336853, Serial Number: 336853;  UDI: (01)00884838059863(21)336855, Serial Number: 336855;  UDI: (01)00884838059863(21)336854, Serial Number: 336854;  UDI: (01)00884838059863(21)336850, Serial Number: 336850
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The systems were distributed to the following US states: HI, KS, and MO. The systems were distributed to the following foreign countries: Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda.
  • Description du dispositif
    Ingenuity Core128/Elite China 728324
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Adresse du fabricant
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA