Events

Rappel de Device Recall Gemini TF 16 and Gemini TF 64 PET/CT Systems Software Versions 3.5.1 and 3.5.1.1

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
    60933
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0805-2012
  • Date de mise en oeuvre de l'événement
    2011-12-02
  • Date de publication de l'événement
    2012-01-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106832
  • 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
    Philips received notification by a customer of an issue relating to unwanted auto delete occurrences resulting in raw data being deleted and, in some cases, raw data being deleted immediately after scan acquisition but before images are reconstructed.
  • Action
    Philips Medical System sent a Urgent Medical Device Correction letter dated December 5, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The following are recommended actions: 1. Please ask your local Philips Service Engineer to ensure that the Auto Delete function is configured to run automatically. 2. Please share this information with all Philips GEMINI TF system operators at your site. 3. Retain this document with your system's instructions for Use Manual. For further information or support concerning this issue please contact your local Philips representative in the United States and Canada at 1-800-722-9377, and follow the recorded menu options to reach Customer Solutions Engineer; in all other countries please dial your local Philips Healthcare office.

Device

Device Recall Gemini TF 16 and Gemini TF 64 PET/CT Systems Software Versions 3.5.1 and 3.5.1.1
  • Modèle / numéro de série
    Product Code 882470, Seriel #'s: 7003-7006, 7008-7011, 7014, 7015, 7017-7026, 7031, 7034-7036, 7039, 7041, 7043, 7045, 7047, 7049, 7050-7054, 7058, 7060, 7062, 7064, 7066, 7068, 7069, 7073-7075, 7077, 7080, 7081, 7084-7087, 7089, 7093-7099, 7104, 7106-7108, 7112, 7114, 7115, 7118, 7120-7123, 7125, 7128, 7129, 7131, 7133, 7135, 7137-7140, 7142, 7143, 7145, 7147, 7148, 7156, 7159, 7161, 7163, 7165, 7166, 7168, 7170, 7173, 7174, 7176, 7177, 7181, 7183-187, 7193-7200, 7205, 7208, 7210, 7211, 7215, 7216, 7220, 7223 & 7224.  Product Code 882471, Seriel #'s: 7007, 7012, 7013, 7016, 7027-7030, 7032, 7042, 7044, 7055, 7057, 7059, 7061, 7063, 7065, 7067, 7071, 7072, 7076, 7078, 7079, 7082, 7083, 7088, 7091, 7092, 7102, 7103, 7105, 7109, 7110, 7116, 7117, 7119, 7126, 7132, 7136, 7141, 7144, 7146, 7149, 7152-7154, 7158, 7160, 7164, 7167, 7169, 7171, 7172, 7175, 7178-7180, 7182, 7188-7190, 7192, 7201-7204, 7206, 7209, 7212-7214, 7217-7219 & 7221.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NY, OH, OR, PA, PR, TN, TX, WA and WV. and the countries of: Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Denmark, Egypt, France, Germany, Hungary, India, Israel, Italy, Japan, Netherlands, Pakistan, Philippines, Poland, Russian Fed, Saudi, Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine and United Kingdom.
  • Description du dispositif
    GEMINI TF 16 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model # 882470 & GEMINI TF 64 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model #882471 Philips Medical Systems, Highland Heights, OH || The device is a diagnostic imaging system for fixed or mobile installations that combines 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 Road, Cleveland OH 44143-2131
  • Source
    USFDA