Events

Recall of Philips BV300 Mobile X-Ray System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems.

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
    25248
  • Event Risk Class
    Class 2
  • Event Number
    Z-0526-03
  • Event Date Posted
    2003-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25458
  • 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, Mobile - Product Code IZL
  • Reason
    The c-bow support can bend and break allowing c-arm to fall from support.
  • Action
    The firm issued a letter dated 9/27/02 to their customers. The letter advised of the problem and that a service representative will visit to inspect unit and correct.

Device

Philips BV300 Mobile X-Ray System
  • Model / Serial
    Part numbers 9896 000 06801 and 9806 000 06802 with serial numbers: DBXXXX - all DBXXXX - all DDXXXX - all DEXXXX - all DG0001-DG0129 DH0001-DH0033 DJ0001 - DJ0152 DK0001 - DK 0076
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributed to hospitals, x-ray centers and medical centers throughout the U.S.
  • Product Description
    Philips BV300 Mobile X-Ray System
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Address
    Philips Medical Systems, 22100 Bothell Everett Highway, Bothell WA 98041
  • Source
    USFDA