Events

Rappel de Device Recall Philips Model EPIQ 5 Ultrasound System.

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems North America Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    67685
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1263-2014
  • Date de mise en oeuvre de l'événement
    2014-02-28
  • Date de publication de l'événement
    2014-03-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126066
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Cause
    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.
  • Modèle / numéro de série
    All systems below software v1.1.2 Which includes software v1 and v 1.1 (All lot codes shipped prior to 2/28/2014).
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Philips Medical Systems North America Inc., 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA