Events

Recall of Precedence SPECT/CT System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Phillips Nuclear Medicine.

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
    45329
  • Event Risk Class
    Class 2
  • Event Number
    Z-0676-2008
  • Event Date Posted
    2008-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65274
  • 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
    Pulse Doppler Ultrasonic Imaging System - Product Code KPS
  • Reason
    Incorrect measurement: the firm discovered a software defect in cardiac and pulmonary viewer software application options used in the precedence ct sub-system. the defect causes incorrect measurements in derived images which are zoomed and saved in a batch file.
  • Action
    A Customer Advisory Notification was mailed to affected consignees on September 28, 2007. The firm informed consignees that incorrect measurement can occur when the Cardiac Viewer or Pulmonary Viewer is used to zoom and save derived images in batch files. The firm provided instructions for operators to prevent incorrect measurements. Phillips is currently investigating methods to correct this issue and will provide updates, free of charge, when they become available. If you have questions concerning this recall, please contact Phillips Medical at 1-800-722-9377, (option5: Diagnostic Imaging, option 5:NM).

Device

Precedence SPECT/CT System
  • Model / Serial
    Model Numbers: 2169-3000A/453560250851;  2169-3001A/453560250861;  2169-3002A/453560253551; and  2169-3003A/453560253561
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of FL, NY, VT, MD, TX, and MO and country of Canada.
  • Product Description
    Philips Medical Systems -- Cardiac Viewer or Pulmonary Viewer software application version 2.0 in use with Precedence SPECT/CT System and all CT EBW workstations using software version 3.5. Philips Nuclear Medicine, Milpitas, CA 95035
  • Manufacturer
    Phillips Nuclear Medicine

Manufacturer

Phillips Nuclear Medicine
  • Manufacturer Address
    Phillips Nuclear Medicine, 540 Alder Dr Bldg 4, Milpitas CA 95035-7443
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA