Events

Recall of Device Recall Practix 300

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

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
    37844
  • Event Risk Class
    Class 2
  • Event Number
    Z-0764-2007
  • Event Initiated Date
    2007-03-23
  • Event Date Posted
    2007-09-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51931
  • 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
    X-ray systems - Product Code IZL
  • Reason
    X-ray systems lack product report certification demonstrating compliance, and were illegally introduced into the united states commerce.
  • Action
    The firm sent letters out via certified mail from 04/03/2007 through 04/09/2007 to consignees informing them of the issue. The letter indicates that the firm plans to replace consignee's systems with the Practix Convenio Mobile X-ray System at no charge by the end of May 2007.

Device

Device Recall Practix 300
  • Model / Serial
    Serial numbers 4561206, 6561652, 6561768, 6561732, 6561728, 6561730, 6561767, 355142, and 06561731
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide: Distributed to Puerto Rico.
  • Product Description
    Practix 300 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are specifically used as mobile X-ray systems for bedside radiological examinations.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA