Events

Recall of Device Recall Tumor Localization (Tumor LOC) software application

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems (Cleveland) Inc.

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
    50824
  • Event Risk Class
    Class 2
  • Event Number
    Z-1542-2009
  • Event Initiated Date
    2009-01-28
  • Event Date Posted
    2009-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77411
  • 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, x-ray, tomography, computed - Product Code JAK
  • Reason
    A software error in the tumorloc software was discovered upon receipt of a customer complaint. there is the potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series id.
  • Action
    Philips Medical issued an 'URGENT -Medical Device Correction' document dated January 28, 2009. This notification informs consignees of the TumorLoc imaging issue, the inherent hazards involved should this problem occur, the circumstances under which this problem may occur and corrective actions which the user/customer should perform in the event that this problem is encountered. It also informs that user/customer that Philips will have their Service Engineers contact the customers within 6 months to install a TumorLoc upgrade. For further questions, contact the Phillips Customer Care Center at 1-800-722-9377.

Device

Device Recall Tumor Localization (Tumor LOC) software application
  • Model / Serial
    Lot Numbers: 7001-7354 for BB; and 8222, 8270, 8709, 8838, 8841, 8862, 8986, 9014, 9019, 9127, 9166, 10331, 10348, 10364, 10402, 10705, 10827, 11002, 11047, 11055, 11096, 11362, 11588, and 11597, for EBW.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Jordan, Libyan Arab Jamahiriya, Lithuania, Malaysia, Netherlands Antilles, Netherlands, New Zealand, Norway, Philippines, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Tahiti, Taiwan, Thailand, United Kingdom and Venezuela.
  • Product Description
    TumorLoc software for the Brilliance Big Bore (BB) and the CT Extended Brilliance Workstation (EBW), Model #4550 116 02431 (TumorLoc). || The BB is a CT X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA