Events

Rappel de Device Recall BrightView and BrightView X

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-0510-2018
  • 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=161313
  • 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 BrightView and BrightView X
  • Modèle / numéro de série
    BrightView X, Model # 882478 Serial Numbers: 11000044 11000006 11000033 11000025 11000105 11000016 11000072 11000116 11000003 11000018 11000066 11000047 11000101 11000065 11000114 11000078 11000051 11000046 11000026 11000007 11000010 11000027 11000032 11340001 11000055 11000070 11000084 11000088 11000068 11000052 11000057 11000050 11000067 11000102 11000061 11000095 11000023 11000094 11000060 11000054 11340004 11000083 11000091 11000098 4000570 11000063 11000062 11000013 11000015 11000035 11000081 11000009 11000017 11000110 11000090 11000107 11340003 11000056 11000029 11000100 11000019 11000034 11000020 11000112 11000086 11000045 11000092 11000037 11000106 11000038 11000059 11000064 11000039 11000087 11000004 11000058 11000030 11340005 11000113 11000117 11000011 11000118 11000074 11000075 11000036 11000104 11000103 11000071 11340002 11000089 11000012 11000041 11000042 11000043 11000049 11000014 11000099 11000022 11000031 11000005 11000028 11000073 11000040 11000077 11000008 11000048 11000093 11000096 11000097 11000069 11000079 11000080 11000024 11000076 11000085 11000108 11000109 11000115
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Description du dispositif
    BrightView X, Model #882478 || Product Usage: || BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).
  • 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