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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON SC2000

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  Class 2 Device Recall ACUSON SC2000 see related information
Date Initiated by Firm December 22, 2013
Date Posted January 24, 2014
Recall Status1 Terminated 3 on March 05, 2015
Recall Number Z-0825-2014
Recall Event ID 67226
510(K)Number K123622  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product 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.
Code Information 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. 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
685 E Middlefield Rd
Mountain View CA 94043-4045
For Additional Information Contact Sheia Pickering
650-694-5398
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 271 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA INC.
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