Events

Recall of BD Phoenix System software update disk

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Co..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61692
  • Event Risk Class
    Class 2
  • Event Number
    Z-1658-2012
  • Event Initiated Date
    2012-04-10
  • Event Date Posted
    2012-05-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108725
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Reason
    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 System software update disk
  • Model / Serial
    BD Phoenix Update Disks (PUD) versions: 4.51 R, 4.56G, 4.61A, 4.65A, 4.71A, 4.75A, 4.81A, 4.85A, 4.91A, 5.11A, 5.15A, 5.21A
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Becton Dickinson Phoenix Update Disks (PUD), catalog # 441107/ 448047, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. || Product Usage: || The Phoenix Update Disk (PUD) delivers substrate and drug specific information to be used by the BD Phoenix instrument software in || determining organism identification and susceptibility results. Information contained in the PUD does not change instrument functionality || or features.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA