Events

Recall of Device Recall Philips Model EPIQ 5 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 North America 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
    67685
  • Event Risk Class
    Class 2
  • Event Number
    Z-1263-2014
  • Event Initiated Date
    2014-02-28
  • Event Date Posted
    2014-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126066
  • 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, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Reason
    A problem has been detected with philips model epiq 5 and 7 ultrasound system. the system will report incorrect doppler velocities if you use high pulse repetition frequency (hprf) with multiple sample volume gates. while in high pulse repetition frequency (hprf) in display zoom velocity scale using manual spectral doppler trace, the velocities in the velocity results table may be overstated by.
  • Action
    The firm, Philips Healthcare Ultrasound, sent an "Medical Device Correction" letters dated 2014 Feb 28 via Certified Mail via the USPS by March 5, 2014. The letters described the product, problem and actions to be taken. The customers were instructed to not use HPRF in PW Doppler mode, to avoid the noted issues. Philips Field Service Engineer will be contacting them to schedule software upgrade to the systems free of charge. If you need any further information or support concerning this issue, please contact the Quality Specialist II at 978-659-4519 or your local Philips representative.

Device

Device Recall Philips Model EPIQ 5 Ultrasound System.
  • Model / Serial
    All systems below software v1.1.2 Which includes software v1 and v 1.1 (All lot codes shipped prior to 2/28/2014).
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: AL, AK, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NM, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WV; and countries of: Australia, Austria, Belgium, Canada, Chili, Ecuador, Egypt, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Korea Rep, Malaysia, Netherlands, New Zealand, Norway, Peru, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom.
  • Product Description
    Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. || Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 || EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence, location and severity of cardiac or vasculare stenosis.
  • Manufacturer
    Philips Medical Systems North America Inc.

Manufacturer

Philips Medical Systems North America Inc.
  • Manufacturer Address
    Philips Medical Systems North America Inc., 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA