Events

Rappel de ACUSON SC 2000 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
    57289
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0827-2011
  • Date de publication de l'événement
    2010-12-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95747
  • 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, ultlrasonic - Product Code IYN
  • Cause
    There is the possibility of a short occurring in the transducer which could cause focal heating on the probe face.
  • Action
    SIEMENS issued a filed correction in the form of a "Customer Safety Advisory Notification" initiated on September 29, 2010 and mailed to customers by Federal Express on the same day. The notification described the product, problem and actions to be taken by the customers. The customers were instructed to examine the 4Z1c transducer prior to use (Note: if transducer does not show a blister on its front face or does not feel unusually when it is safe for use); to immediately discontinue use and contact their local Siemens representative to get issue resolved, if the transducers developed a hot spot that exhibits a visible blister on the patient contact surface and feels hot to the touch during operation, and to pass this notice on to all those within their organization who need to be aware. If you have any questions, please contact (650) 969-9112 or (800) 422-8766.

Device

ACUSON SC 2000 ultrasound system
  • Modèle / numéro de série
    Material Number: 10033682: Serial number of systems: 400212 400213 400215 400251 400405 400240 400089 400090 400104 400109 400149 400171 400289 400302 400334 400337 400183 400218 400209 400219 400259 400126 400247 400257 400260 400263 400281 400116 400165 400214 400420 400216 400253 400403 400412 400343 400185 400026 400044 400045 400084 400086 400088 400091 400102 400111 400114 400117 400118 400121 400124 400129 400132 400135 400139 400142 400143 400145 400146 400148 400156 400162 400168 400174 400176 400179 400202 400203 400206 400217 400220 400221 400222 400223 400224 400225 400227 400228 400229 400230 400232 400233 400234 400235 400236 400238 400239 400242 400243 400244 400258 400268 400269 400270 400272 400282 400287 400288 400290 400291 400293 400295 400297 400303 400304 400312 400314 400316 400336 400435 400449 400294 400127 400043 400125 400199 400200 400208 400113 400120 400237 400241 400332 400335 400413 400419 400158 400160 400161 400170 400172 400181 400182 400184 400187 400191 400201 400211 400249 400250 400299 400115 400155 400157 400207 400416 400424 400189 400195 400197 400166
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA and countries including: Australia, Belgium, Brazil, China, Czech Republic, Finland, France, Germany, India, Ireland, Italy, Japan, Kenya, Malaysia, Netherlands, Norway, Portugal, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom.
  • Description du dispositif
    ACUSON SC 2000 ultrasound system. || Siemens Medical Solutions USA, Inc. || Business Unit Ultrasound || 1230 Shorebird Way || Mountain View, CA 94043 || Intended use: SC2000 ultrasound system is intended for the following applications: Cardiac, neo-Natal and fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medial 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., 1230 Shorebird Way, P.O. Box 7393, Mountain View CA 94043
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA