ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz
Medical device recall Z-0825-2014. Published in FDA’s Enforcement Report on Feb 5, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 5, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 271 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
271 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,852 characters
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.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 22, 2013.
- FDA classified it on Jan 24, 2014.
- FDA’s Enforcement Report published it on Feb 5, 2014.
- FDA terminated it on Mar 5, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Medical Solutions USA, Inc., of Mountain View, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.