Events

Rappel de Siemens SOMATOM Go.Up

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
    80047
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1940-2018
  • Date de mise en oeuvre de l'événement
    2018-04-20
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164276
  • 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, x-ray, tomography, computed - Product Code JAK
  • Cause
    There is a potential for a software issue that may cause the need for necessary patient rescans.
  • Action
    The firm, Siemens Healthineers, sent an "Customer Safety Advisory Notices" letter dated 4/20/2018 beginning on 4/20/18 to its customers. The letter described the product, problem and actions to be taken. The letters provided the following information to customers: How can the operator help to avoid a potential risk of the system? To avoid an unnecessary additional X-ray dose to patients please observe the following instructions: Topic 1: If a reconstruction cannot be started after an examination, please reboot the system and repeat the aborted reconstruction. If the error persists, please contact your local Siemens Healthineers service support team. They can help you to decide whether a rescan is necessary or not. Topic 2: If you change the scan parameters kV or mA (tube HV or current), please wait for at least 12 seconds before you trigger a scan command on the control box. If artifacts are visible in the topogram, please repeat the topogram before starting the volume scan. If you have started a volume scan and detect artifacts in the real time display, please stop the scan immediately to avoid an unnecessary X-ray dose. Topic 3: After an osteoporosis scan has been completed, the Osteo reconstruction needs to be started and completed directly after the scan. Therefore the images should be loaded and checked in CT View&Go; before the scan/recon tab card is closed. Please do not close the scan/recon tab card before you have reconstructed and checked all Osteo images. A successful and complete Osteo reconstruction is visualized by full green bars in the column Recon Progress of the Job Status table and by images including the Osteo phantom in the tab card CT View&Go; (for details please see Fig. 3 below). An example of a correct Osteo reconstruction is provided in Fig. 2. After checking the successful and complete Osteo reconstruction you may close the scan/recon tab card. What has been done to address these issues? What actions shall be t

Device

Siemens SOMATOM Go.Up
  • Modèle / numéro de série
    Serial Numbers: 108052,  108053,  108054,  108055,  108056,  108057,  108058,  108059,  108060,  108061,  108062,  108063,  108064,  108065,  108066,  108067,  108068,  108069,  108070,  108071,  108072,  108073,  108074,  108075,  108076,  108077,  108078,  108079,  108080,  108081,  108082,  108083,  108084,  108085,  108086,  108087,  108088,  108089,  108090,  108091,  108092,  108093,  108094,  108095,  108096,  108097,  108098,  108099,  108100,  108101,  108102,  108103,  108104,  108105,  108106,  108107,  108108,  108109,  108110,  108111,  108112,  108113,  108114,  108115,  108116,  108117,  108118,  108119,  108120,  108121,  108122,  108123,  108124,  108125,  108126,  108127,  108128,  108129,  108130,  108131,  108132,  108133,  108134,  108135,  108136,  108137,  108138,  108139,  108140,  108141,  108142,  108143,  108145
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: AR, CA, CT, FL, GA, IL, IN, KS, KY, MO, ND, NY, OH, OK, SD, TN, TX, and VA; and countries of: Algeria, Australia, Austria, Bangladesh, Bolivia, Bosnia Herzog., Brazil, Cambodia, Chile, China, Columbia, Costa Rica, Germany, Greece, India, Indonesia, Italy, Japan, Kenya, Kuwait, Lithuania, Mauritius, Morocco, Nepal, Pakistan, Paraguay, Philippines, Poland, Portugal, Republic Korea, Romania, Senegal, Singapore, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, Ukraine, and United Kingdom.
  • Description du dispositif
    SOMATOM Go.Up, Material Number 11061628 || There is a potential for a software issue that may cause the need for necessary patient rescans.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA