Events

Recall of Philips Diagnostic Ultrasound 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
    49065
  • Event Risk Class
    Class 2
  • Event Number
    Z-0522-2009
  • Event Initiated Date
    2008-08-12
  • Event Date Posted
    2008-12-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72768
  • 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
    Ultrasonic Pulsed Doppler Imaging System - Product Code IYN
  • Reason
    The system has a software defect that affects the display of estimated fetal weight (efw) growth percentile result values.
  • Action
    On 8/12/08, the firm sent an Urgent - Medical Device Correction letter, dated July 2008, to all affected customers via UPS. The letter describes the reason for the recall, informs them that Philips Ultrasound is correcting the error, states that the software is under development, will be available in September 2008 and will contact the customer to upgrade their system. "In the interim, Philips recommends that you only use the Hadlock or Osaka growth tables to perform your EFW Growth Percentile calculations. You should make the appropriate selections in the Analysis Setup menu on your system."

Device

Philips Diagnostic Ultrasound System
  • Model / Serial
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bosnia, Brazil, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Dominican Rep, Ecuador, Egypt, El Salvador, France, Germany, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Jordan, Kuwait, Malaysia, Martinique, Mexico, Moldova, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syrian Arab Rep, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Utd Arab Emirr., Venezuela, Viet Nam, Canada, Afghanistan, Albania, Argentina, Australia, Austria, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Italy, Japan, Korea Rep, Latvia, Lebanon, Lithuania, Malaysia, Mauritius, Mexico, Moldova, Morocco, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Paraguay, Peru, Poland, Portugal, Puerto Rico, Romania, Serbia, Singapore, SLOVAKIA, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, Ukraine, United Kingdom, Uzbekistan, Venezuela, and Virgin Isl (Br).
  • Product Description
    Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. || Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body.
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Address
    Philips Medical Systems, 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA