Events

Recall of MX8000 Computed Tomography Xray System

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
    26080
  • Event Risk Class
    Class 3
  • Event Number
    Z-0835-03
  • Event Initiated Date
    2003-04-02
  • Event Date Posted
    2003-05-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27028
  • 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
    Patient images may be incorrectly stored in the archive directory of a different patient.
  • Action
    The firm mailed a ''Product Safety Notification'', dated 4/2/2003, to all affected user sites.

Device

MX8000 Computed Tomography Xray System
  • Model / Serial
    Serial Numbers: 3094 through 3196.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The units were installed in medical facilities located nationwide, and in the following foreign countries: China, Belgium, France, Austria, Germany, Italy, Netherlands, Australia, Israel, Spain, Denmark, Singapore, Switzerland, Russia, South Korea, Canada, United Kingdom, South Africa, Sweden, Japan, Brazil.
  • Product Description
    Philips MX8000 IDT CT Scanner, utilizing V2.1 software.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Highland Heights OH 44143
  • Source
    USFDA