Events

Rappel de Device Recall ACUSON SC2000 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 Siemens Medical Solutions USA, 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
    70362
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1056-2015
  • Date de mise en oeuvre de l'événement
    2015-01-12
  • Date de publication de l'événement
    2015-02-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-11-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133313
  • 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
    The bolt holding the control panel of the acuson sc2000 in a fixed position may fail and the control panel cannot be locked into position.
  • Action
    Siemens Medical sent an Customer Safety Advisory Notification to all affected customers on January 12, 2015 , via Certified mail, return receipt requested.The letter identified the product the problem and the action needed to be taken by the customer. At this time there is not mitigation to avoid risk associated with this issue. Local Customer Service Engineers will be contacting each site to replace the console. Until the necessary repairs have been completed, please share the information with all uses of the device. If you have any questions, please contact your local service support person for information regarding timelines and status. Until the necessary repairs have been completed on your system, please share this information with all personnel within your organization who need to be aware of this issue. As always, patient safety issues are a very high priority. To date, no patient injury has been reported. This problem was discovered as part of our ongoing quality process. We sincerely regret any inconvenience this condition may cause in your daily operations. For further questions please call (650) 694-5398.

Device

Device Recall ACUSON SC2000 Ultrasound System
  • Modèle / numéro de série
    Model number 10433816. serial numbers 401100 to 401400.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA and the countries of Australia, Austria, Belarus, Canada, Ecuador, Finland, France, Georgia, Germany, India, Iraq, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeria, P.R. China, Philippines, Portugal, Republic Korea, Russian Fed., Saudi Arabia, Serbia, South Africa, Spain, Suriname, Sweden, Taiwan, Turkey, U.A.E. and United Kingdom.
  • Description du dispositif
    ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. || The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc., 685 E Middlefield Rd, Mountain View CA 94043-4045
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA