Events

Rappel de ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35)

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
    68197
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1668-2014
  • Date de mise en oeuvre de l'événement
    2014-04-23
  • Date de publication de l'événement
    2014-05-28
  • 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=127127
  • 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
    Potential malfunction due to a software issue for acuson sc2000 ultrasound systems using software version 3.5 (va35) when using the stress echo feature which could cause the need for the study to be repeated.
  • Action
    Siemens sent a Consumer Safety Advisory Notification letter on April 23, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the stress echo feature with software version .5. For studies acquired with systolic-only captures: review all patient studies on exams performed after software revision 3.5 was installed on your system. If you are unsure when this software was installed on your system, please contact your local Customer Service representative. Foreign distributors will implement distribution of the field correction to their customers. For questions regarding this recall call 650-694-5398.

Device

ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35)
  • Modèle / numéro de série
    ACUSON SC2000 model number: 10433816; Stress Echo Feature model number: 1044966 Serial numbers - USA: 400290 400425 400439 400441 400443 400447 401176 400787 400789 400790 400791 400792 400794 400797 400063 400877 401187 401441 401590 401602 401638 400174 401612 401501 401507 401561 400297 401423 401429 401550 401491 401494 401562 401572 401584 401621 400570 401010 401020 401235 401252 401564 401611 400998 400999 400979 401625 401631 400234 400312 400972 401645 400108 400177 400203 400313 400650 400663 400664 400176 400712 400716 401565 400128 400142 400887 400889 401043 401257 401559 401576 400474 400902 400860 400875 400912 400925 401387 401476 401477 401547 401496 401567 401569 401570 401597 401607 400630 401558 401587 401644 400227 400473 400577 400649 401294 401600 ROW:  400652 400733 400737 400746 401437 401443 401478 401495 401650 400546 401506 401371 401325 401581 401620 401623 400302 400348 400347 400553 400558 400726 400995 400996 401120 401123 401209 401260 401338 401344 401442 401452 401551 401555 401556 401522 401560 401577 401579 401588 401589 401603 401604 401606 401643 401699 400125 400200 401434 401626 401615 400155 400180 400307 400704 401428 401541 401624 401004 401546 401519 401627 400247 400263 400511 401045 400497 400284 400252 401502 400655 400214 400253 400836 400840 401118 400218 400990 401127 401180.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belarus, Dominican Rep., France, Germany, India, Indonesia, Israel, Japan, Mexico, New Zealand, Norway, Philippines, Poland, Republic of Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Sweden, Switzerland, Turkey, U.A.E., Ukraine, and United Kingdom.
  • Description du dispositif
    ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.
  • 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