Recall of Device Recall Brilliance CT Big Bore Oncology

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
    71177
  • Event Risk Class
    Class 2
  • Event Number
    Z-1648-2015
  • Event Initiated Date
    2015-03-16
  • Event Date Posted
    2015-05-22
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2017-02-22
  • Event Source
    USFDA
  • Event Source URL
  • 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 firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
  • Action
    On 3-18-2015 the firm sent Urgent Field Safety Notices to their customers.

Device

  • Model / Serial
    System Code #, 728243, Serial #, 7039
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in China.
  • Product Description
    Brilliance CT Big Bore Oncology. || Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
  • Manufacturer

Manufacturer

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