Events

Rappel de GEMINI LXL, TF 16 and TF64, PET & XRay CT scanning systems

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
    63822
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0882-2013
  • Date de mise en oeuvre de l'événement
    2012-10-24
  • Date de publication de l'événement
    2013-02-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-07-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114844
  • 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
    Software anomaly. philips determined that the tumorloc software program for the referenced pet/ct x-ray scanning systems has the capability to generate intensity projection data sets from respiratory gated data. a circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. if the flipped intensity project.
  • Action
    Philips Medical issued an URGENT - Medical Device Correction letter to their customers concerning the Tumor LOC IPD issue on October 25, 2012. The letter informs the customer of the nature of this software problem and names the Brilliance and GEMINI scanning systems affected by this issue. The letter goes on to describe the hazard inherent to this software issue and provides 'Workaround procedures which the customers can use in order to help mitigate the effects of this problem. Customers with questions should contact their Customers Care Solutions Center at 1-800-722-9377, option 5. For questions regarding this recall call 1-800-722-9377.

Device

GEMINI LXL, TF 16 and TF64, PET & XRay CT scanning systems
  • Modèle / numéro de série
    The affected GEMINI systems are identified with the following Serial Numbers: GEMINI LXL Model # 882412, Serial Numbers: 14702 and 14707; GEMINI TF 16 Model #882470, Serial Numbers: 7129, 7121, 7123, 7128, 7096, 7133, 7185, 7187, 7226, and 7220;  GEMINI TF 16, Model #882473, Serial Numbers: 7150, and and 7237;GEMINI TF 64, Model #882471, Serial Numbers: 7103, 7126, 7132, 7158, 7160, 7164, 7175, 7178, 7179, 7218, 7229, 7221, 7245, 7550, 7255, and 7256.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AK, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, OA MA, MD MI, MN, MO, MS, NC, D, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; Internationally to Canada and other countries..
  • Description du dispositif
    Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
  • 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