Events

Rappel de Device Recall Axis Gamma Camera

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
    45894
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1510-2008
  • Date de mise en oeuvre de l'événement
    2007-11-21
  • Date de publication de l'événement
    2008-09-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66436
  • 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
    Scintillation (gamma) camera - Product Code KPS
  • Cause
    Resistor failure: the rotate motion shunt resistor may overheat and results in the appearance of smoke, a burning smell, and an electronic stop condition, which will disable the gamma camera rotate motion and all other motions.
  • Action
    Consignees were sent an Urgent Field Safety Notice on 1/30/08. The letter instructs users who experience a failure to remove the system from service and contact the recalling firm for immediate correction. The recalling firm will schedule appointments with users to replace the affected part beginning in March 2008. For additional information, contact 1-800-722-9377.

Device

Device Recall Axis Gamma Camera
  • Modèle / numéro de série
    Model Numbers: 210714, 210880 and 211037 Part Numbers: 4535 665 13461, or N210714 Axis System, 3/8" Crystals 4535 665 16601, or N210880 Axis System 3/4" Crystals 4535 665 12921, or N211037 Axis System 3/8 Precision 4535 665 13501, or N211039 Axis System 3/4 Precision 4535 679 46301, or N211280 Axis System 3/8 Precision 4535 671 67421, or N211282 Axis System 3/4 Precision (Note: Due to a part number scheme change at the firm, either number is representative of the identified system)
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV, Puerto Rico and countries of Argentinia, Austrailia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Iceland, India, Ireland, Israel, Italy, Japan, Netherlands, Norway, Philipines, Poland, Singapore, South Africa, Spain, Switzerland, and United Kingdom.
  • Description du dispositif
    Axis Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143
  • 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