Events

Recall of Device Recall ACUSON SC2000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67226
  • Event Risk Class
    Class 2
  • Event Number
    Z-0825-2014
  • Event Initiated Date
    2013-12-22
  • Event Date Posted
    2014-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125034
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Reason
    The locking mechanism that is intended to hold the control panel in a fixed position can become loose and fail to lock the rotation of the control panel, making it unable to steer or control during transport.
  • Action
    Customer Safety Advisory Letters were sent to all affected users on December 22, 2013. Letters advised of the issues and the actions they should take until a Siemens Field Engineer will visit and upgrade the control panel.

Device

Device Recall ACUSON SC2000
  • Model / Serial
    Model 10433816; Serial numbers: 401283 401284 401377 401291 401275 401208 401316 401337 401376 401390 401159 401188 401191 401223 401400 401143 401325 401371 401368 401232 401140 401393 401239 401128 401196 401133 401334 401273 401225 401210 401144 401229 401209 401288 401142 401120 401121 401123 401189 401260 401338 401344 401329 401253 401295 401217 401192 401119 401312 401389 401126 401224 401227 401276 401293 401214 401317 401199 401240 401219 401238 401242 401218 401362 401349 401395 401382 401173 401122 401215 401179 401270 401313 401203 401340 401264 401357 401167 401222 401310 401206 401352 401164 401263 401201 401354 401299 401162 401298 401205 401339 401171 401296 401262 401353 401318 401289 401186 401254 401183 401195 401374 401398 401145 401157 401331 401399 401381 401356 401146 401153 401200 401220 401129 401178 401151 401152 401259 401147 401211 401228 401230 401233 401301 401231 401148 401321 401277 401332 401113 401150 401272 401274 401292 401302 401303 401304 401131 401367 401394 401154 401161 401306 401118 401185 401127 401180 401197 401379 401271 401286 401307 401216 401279 401280 401322 401323 401327 401115 401134 401111 401267 401268 401269 401287 401117 401282 401155 401181 401182 401226 401156 401257 401351 401397 401348 401290 401387 401244 401258 401314 401247 401194 401187 401365 401149 401300 401326 401333 401335 401336 401116 401236 401347 401204 401141 401311 401366 401370 401137 401245 401175 401285 401237 401369 401392 401234 401256 401383 401250 401360 401346 401241 401345 401246 401315 401193 401320 401294 401177 401114 401135 401136 401138 401255 401110 401176 401169 401174 401363 401278 401386 401328 401385 401132 401243 401124 401373 401378 401391 401361 401343 401375 401108 401109 401384 401235 401252 401198 401213 401158 401319 401184 401308 401265 401266 401305 401130 401248 401249.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Canada, Ecuador, Finland, France, Germany, India, Ireland, Israel, Italy, Japan, Mexico, 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.
  • Product Description
    ACUSON SC2000 || Power Input: 100-240VAC, 1600 Max 50/60Hz; || Siemens Medical Solutions USA, Inc. || 685 East Middlefield Road || Mountain View, CA 94043 || Ultrasound imaging system.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc., 685 E Middlefield Rd, Mountain View CA 94043-4045
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA