Events

Rappel de Device Recall Precedence 16 , Griffin SPECT/CT Imaging System

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
    79088
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0514-2018
  • Date de mise en oeuvre de l'événement
    2017-12-15
  • Date de publication de l'événement
    2018-02-03
  • 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=161317
  • 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, tomography, computed, emission - Product Code KPS
  • Cause
    During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. the collimator may be partially supported by the cart (e.G. leaning against the cart), or it may fall/slide all the way to the floor.
  • Action
    Philips sent an Urgent Field Safety Notice letter dated December 15, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local Philips representative.

Device

Device Recall Precedence 16 , Griffin SPECT/CT Imaging System
  • Modèle / numéro de série
    Precedence 6 Model # 882351 Serial Numbers :  KP05100002 KP06040012 KP05040006 KP05080007 KP05110003 KP0510008 30008 KP06110019 K06110017 6080522 30007060027 3000034 3000032 30007060029 3000006 KP06020011 KP06050013 KP06080008 KP05110004 KP06110018 30007040026 KP06070015 30007060028 3000033 30007030025 3000031 3000035 3000040 3000041 30058 3000049 3000054 3000039 3000038 3000042 3000093 3000044 3000036 3000043 3000047 KP06070048 3000074 3000059 3000055 340090 3000057 3000058 3000053 3000050 3000056 3000052 3000061 3000051 3000045 3000048 3000069 3000066 3000078 3000060 3000064 3000068 3000065 30007070030 3000071 3000063 3000067 3000062 300072 3000095 3000073 3000085 30007080011 30007040024 3000102 3000075 3000076 7021 3000092 3000098 3000087 3000077 3000082 3000080 3000081 3000088 3000079 3000083 3000084 3000089 3000091 3000096 3000097 3000100 3000086 3000090 3000099 3000094 3000104 3000101 3000103 3000105 3000106 3000037 3000708005 30006120020 30007020023
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Description du dispositif
    Precedence 16 Model # 882350 || Product Usage: || Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals.
  • 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