Events

Rappel de Device Recall Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual

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
    63044
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2451-2012
  • Date de mise en oeuvre de l'événement
    2012-08-21
  • Date de publication de l'événement
    2012-09-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-12-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112361
  • 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 bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
  • Action
    Philips Healthcare sent an Urgent Medical Device Correction letter dated August 22, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that no action needed to be taken at that time b the customer or user. A Philips Field Service Engineer would schule a time to inspect and repair all the affected systems within approximately 6 months. For further information customers were instructed to contact their local Philips representative or contact the Philips Healthcare Customer Care Solution Center at 1-800-722-9377 and follow the recorded menu options toreach a Customer Solutions Engineer. For questions regarding this recall call 440-483-7000.

Device

Device Recall Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual
  • Modèle / numéro de série
    System Code #: 728130; Serial #: 8128, 8158 & 8369.  System Code #: 728256; Serial #: 3695, 3703, 371 &, 3719.  System Code #: 728246; Serial #: 3463, 3508, 3519, 3548, 3552, 3591, 3592, 3593, 3603, 3637, 3648, 3654, 3659, 3661, 3675, 3679, 3687, 3692, 5451, 5515, 5543, 5567, 5583, 5586, 5658, 5664, 5675, 5697, 5707, 5749, 5752, 5774, 5807, 5813, 5815, 5845, 5846, 5852, 5866, 5872, 5910, 5963, 5968, 6028, 6036, 6045, 6071 & 6126.  System Code #: 882160; Serial #: 97, 102, 103, 105, 106, 107, 109, 110, 111, 113, 114, 115, 116, 117, 118, 121, 122, 123, 124, 125, 126, 127, 131, 132, 133, 134, 135, 136, 137, 139, 140, 141, 143, 144, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162 63, 164, 165, 167, 1065 & 6119.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AZ, CA, CO, FL, GA, IL, KS, KY, MI, MS, NJ, NM, NV, NY, OH, TX, WA & WI and internationally to: Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, India, Italy, Japan, Jordan, Mexico, Saudi Arabia, South Korea, Spain, Thailand, Turkey & United Kingdom.
  • Description du dispositif
    Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. || The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. GEMINI Dual is an imaging system that combines positron emission tomography (PET) and X-ray computed tomography. The GEMINI produces attenuation and non-attenuation corrected images of the distribution of PET radiopharmaceuticals in the head, body and total body as well as X-ray transmission images of these areas. The PET and CT images are registered and displayed in a fused format to provide combined PET and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an integrated system or as a stand-alone PET or CT system. GEMINI can provide CT data suitable for use in attenuation correction.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

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