Events

Recall of Device Recall Philips brand MX8000 IDT CT Scanner 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
    27979
  • Event Risk Class
    Class 2
  • Event Number
    Z-0786-04
  • Event Initiated Date
    2004-03-08
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30839
  • 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
    The ct couch may move downward to its lower limit without command.
  • Action
    The firm contacted their Field Service Personnel by letter on 3/8/2004. The letter instructs the field personnel to immediately install the corrective firmware kits (from Siemens) on all affected units in the field.

Device

Device Recall Philips brand MX8000 IDT CT Scanner System
  • Model / Serial
    Serial Numbers: 2501 to 2554; 3006; 3008 to 3337.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The systems were installed at medical facilities located nationwide and worldwide.
  • Product Description
    Philips MX8000 IDT CT Scanner System, 10 & 16 slice images.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA