Events

Recall of Device Recall Philips Bucky Diagnost FS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems Sales & Service Region No. America.

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
    27827
  • Event Risk Class
    Class 2
  • Event Number
    Z-0268-04
  • Event Initiated Date
    2003-11-18
  • Event Date Posted
    2003-12-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30592
  • 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, Stationary - Product Code KPR
  • Reason
    Support chain attachment on the bucky carriage may fail and cause the counter weights or x-ray tube to fall.
  • Action
    The firm mailed a letter to their customers on November 18, 2003 stating upgrades will begin November 14, 2003.

Device

Device Recall Philips Bucky Diagnost FS
  • Model / Serial
    Site numbers: 504495, 105355, 104447. The firm uses site numbers instead of serial numbers.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributed to three medical facilities in Florida, New York and California.
  • Product Description
    Bucky Diagnost FS Part number 9890-010-83651
  • Manufacturer
    Philips Medical Systems Sales & Service Region No. America

Manufacturer

Philips Medical Systems Sales & Service Region No. America
  • Manufacturer Address
    Philips Medical Systems Sales & Service Region No. America, 22100 Bothell Everett Highway, Bothell WA 98041
  • Source
    USFDA