Events

Rappel de Device Recall MicroMaxx ultrasound system and MTurbo 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 Sonosite, 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
    59442
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0057-2012
  • Date de mise en oeuvre de l'événement
    2011-07-18
  • Date de publication de l'événement
    2011-10-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102808
  • 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
    This is a software anomaly. in some circumstances, if the systolic/diastolic (s/d) ratio value is interpreted directly from the display, the clinician could potentially use an incorrect value of the s/d ratio in his/her assessment.
  • Action
    The firm SonoSite, Inc., sent an "Urgent - Medical Device Correction" letter dated September 29, 2011 to its foreign and domestic customers. The letter described the product, problem, and actions to be taken. The customers were instructed to follow the three (3) steps provided in the letter to verify if the extended OB/GYN Calculations (EOBC) is enabled on their system. Additionally, SonoSite will perform a software upgrade to M-Turbo and/or MicroMax ultrasound system in order resolve the issue. The customers were instructed to contact Sonosite Technical Support via website: www.sonosite.com/sdratio; email: regulatory@sonosite.com (include contact information and address), or call in U.S. and Canada: 1-877-590-4982. If you have any questions or concerns regarding this matter, do not hesitate to contact in US and Canada at 1-877-657-8118, Monday-Friday, 6 am-5 pm PST. Customer can also send an email to Technical Support at service@sonosite.com

Device

Device Recall MicroMaxx ultrasound system and MTurbo ultrasound system
  • Modèle / numéro de série
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including Puerto Rico; and countries of: Afghanistan, Algeria, American Samoa, Argentina, Australia, Bolivia, Botswana, Brazil, Canada, China, Costa Rica, Cyprus, Dominican Republic, Estonia, France, Gambia, Germany, Great Britain, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Mauritius, Mexico, Netherlands, New Zealand, Nigeria, Northern Mariana Islands, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Tanzania, Uganda, United Arab Emirates, Viet Nam, and Zambia.
  • Description du dispositif
    MicroMaxx ultrasound system and M-Turbo ultrasound system is Medical Diagnostic Ultrasound. || General purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body.
  • Manufacturer
    Sonosite, Inc.

Manufacturer

Sonosite, Inc.
  • Adresse du fabricant
    Sonosite, Inc., 21919 30th Dr SE, Bothell WA 98021-3904
  • Société-mère du fabricant (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA