Events

Rappel de BD Phoenix Automated Microbiology System Software for Automated Microbiological System

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 Becton Dickinson & Co..

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
    61692
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1657-2012
  • Date de mise en oeuvre de l'événement
    2012-04-10
  • Date de publication de l'événement
    2012-05-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108724
  • 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, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Cause
    Bd identified an increase in vancomycin-resistant strains that may exhibit erroneous results on all pmic or pmic/id panels and could lead to ineffective treatment regimen in affected patients.
  • Action
    Becton Dickinson (BD) sent an Urgent Field Correction Action letter dated April 2012 and an Update letter dated April 18, 2012 to all affected customers via e-mail and UPS overnight delivery. The letter identified the affected products, problem and actions to be taken. The letter provided specific workaround instructions for device users pending software upgrades. A BD Service Engineer will contact affected customers to arrange for the installation of the updated software when it becomes available. The letter included an Acknowledgement Form to be completed. For questions contact Technical Services at 800-638-8663.

Device

BD Phoenix Automated Microbiology System Software for Automated Microbiological System
  • Modèle / numéro de série
    Software versions: 5.55R, 5.66A, 5.70A, 5.75A, 5.83A, and 6.01A
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT ,DC ,FL , GA, IA, IL, IN, KY, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, AND WY. and the countries of Canada, Australia, Philippines, Thailand, Malaysia, India, New Zealand, Belgium, Singapore, Japan, Taiwan, China, Chile, Colombia, Korea, Brazil and Venezuela.
  • Description du dispositif
    Becton Dickinson Phoenix System Software, catalog # 448035/448046, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. || Product Usage: || Automated Microbiology System for the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of Gram Positive bacteria from pure culture.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Adresse du fabricant
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA