Events

Recall of Device Recall BuckyDiagnost with Optimus Generator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Healthcare 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
    58077
  • Event Risk Class
    Class 2
  • Event Number
    Z-0905-2011
  • Event Initiated Date
    2011-01-17
  • Event Date Posted
    2011-03-04
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98273
  • 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
    Diagnostic X-Ray High Voltage Generator - Product Code IZO
  • Reason
    Affected systems were determined not to prevent run-on of a selected technique factor if the technique selector and the exposure control were activated simultaneously.
  • Action
    A Customer Information BuckyDiagnost Diagnostic X-Ray System letter, dated January 6, 2011, was sent to customers. The letter identifies the affected product, the reason for the recall, actions that are to be taken by customers, and actions that are planned by the firm. Customers are advised to make sure that the desired exposure values are displayed and that they have released the technique button BEFORE they start the exposure by pressing the exposure switch whenever manually changing the exposure parameters and in order to avoid the problem. Philips will issue a Field Change Order (FCO) to resolve the issue by updating the system software free of charge. Philips will contact customers to implement the FCO. Further information or support concerning this issue can be obtained by contacting your local Philips representative. The Field Service Engineers began software implementation the week of March 21, 2011.

Device

Device Recall BuckyDiagnost with Optimus Generator
  • Model / Serial
    704031 / 70408
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    BuckyDiagnost general purpose x-ray system with Optimus Generator. || General Purpose Diagnostic Radiography.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Manufacturer Address
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA