Events

Recall of Device Recall Computed Tomography XRay System MX 8000 IDT 16

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
    56508
  • Event Risk Class
    Class 2
  • Event Number
    Z-0133-2011
  • Event Initiated Date
    2010-07-27
  • Event Date Posted
    2010-10-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94177
  • 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
    Philips healthcare has decided to recall the computed tomography x-ray system mx 8000 idt due to the fact that the software upgrade for the mx 8000 idt 16 v4.2.1 may not provide the optional collimation of 4x4.5 (18mm). if the customer does not verify the increment and thickness coincide with the newly selected collimation suggested by the conversion report, there is potential for a 6mm gap to ap.
  • Action
    Philips Medical Systems (Cleveland), Inc. sent an URGENT - Field Safety Notice dated July 29, 2010 and August 23, 2010 to all customers. The notices identified the product, the problem, and the steps to be taken. Customers were instructed to locate and correct the error. Field Service Engineers were to visit each site to update the software For further information customers were to contact their local Philips Customer Care Center at 1-800-722-9377

Device

Device Recall Computed Tomography XRay System MX 8000 IDT 16
  • Model / Serial
    Model # 728120; Serial #'s: 2513, 2518, 3147, 3217, 3014, 3050, 3068, 3188, 3091, 3051, 3099, 3126, 3183, 3303, 2539 & 3056.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was sold in the following states: CA, DE, IN,OR, MA, NV, TN. Product was also sold in Canada and Australia
  • Product Description
    Computed Tomography X-Ray System MX 8000 IDT 16; Model # 728120; Serial #'s: 2513, 2518, 3147, 3217, 3014, 3050, 3068, 3188, 3091, 3051, 3099, 3126, 3183, 3303, 2539 & 3056. || Produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
  • 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