Events

Recall of Device Recall Philips BuckyDiagnost ; Model: 704060/706037

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems, 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
    69090
  • Event Risk Class
    Class 2
  • Event Number
    Z-0364-2016
  • Event Initiated Date
    2014-08-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129612
  • 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
    The hook does not securely hold the footplate in vertical position. therefore the footplate can fall or swing down and may hurt the operator or patient.
  • Action
    The Field Safety Notice FCO70600086 will be mailed on August 19, 2014. Philips Medical Systems will send out certified letters and will have the receipts returned for tracking purposes as well as have a Field Service Engineer visit each site to provide the fix when the Field Change Order is released.

Device

Device Recall Philips BuckyDiagnost ; Model: 704060/706037
  • Model / Serial
    All patient support for stitching are affected.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of MN, KY, MA, VA, TX, NC, HI, FL, AZ, CT, and WY and the countries of Argentina, Australia, Austria, Canada, Denmark, Germany, Netherlands, Russia, Saudi Arabia, Singapore, Spain, and Switzerland.
  • Product Description
    Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • Manufacturer Address
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA