Diagnostic Ultrasound System, ACUSON Juniper, UDI
Medical device recall Z-0748-2022. Published in FDA’s Enforcement Report on Mar 23, 2022.
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 Mar 23, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 2846 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 clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study documentation during a high risk procedure, such as a stress echo exam.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneological, Intraoperative, and Urological applications using different ultrasound transducers for different applications.
2846, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers 550010 550011 550015 550016 550018 550019 550020 550021 550023 550024 550025 550026 550027 550028 550029 550030 550031 550032 550033 550034 550035 550036 550037 550038 550039 550040 550041 550042 550043 550044 550046 550047…
Every code shown here, 1,996 characters
Serial Numbers 550010 550011 550015 550016 550018 550019 550020 550021 550023 550024 550025 550026 550027 550028 550029 550030 550031 550032 550033 550034 550035 550036 550037 550038 550039 550040 550041 550042 550043 550044 550046 550047 550048 550049 550050 550051 550052 550055 550056 550057 550058 550059 550062 550063 550064 550065 550066 550067 550068 550069 550070 550071 550072 550073 550074 550075 550077 550079 550082 550083 550084 550085 550086 550087 550088 550089 550092 550093 550094 550095 550097 550099 550103 550109 550110 550111 550112 550114 550116 550117 550118 550119 550120 550122 550123 550124 550125 550126 550127 550129 550130 550131 550132 550133 550134 550135 550136 550137 550139 550140 550141 550142 550143 550144 550145 550146 550148 550149 550150 550152 550153 550154 550155 550157 550158 550159 550160 550161 550163 550164 550165 550166 550167 550168 550169 550170 550171 550172 550173 550174 550175 550177 550180 550181 550182 550184 550185 550186 550188 550190 550191 550192 550194 550195 550196 550198 550199 550201 550203 550205 550206 550208 550209 550210 550211 550213 550214 550215 550219 550220 550221 550222 550223 550224 550225 550226 550227 550228 550229 550230 550231 550232 550233 550234 550235 550236 550238 550242 550243 550244 550245 550246 550247 550249 550250 550251 550252 550253 550254 550255 550256 550259 550260 550261 550262 550263 550264 550267 550268 550269 550271 550272 550273 550274 550275 550276 550277 550278 550279 550280 550282 550283 550284 550285 550286 550287 550288 550289 550290 550291 550292 550293 550294 550296 550297 550298 550299 550300 550301 550302 550303 550305 550307 550308 550309 550310 550311 550312 550314 550315 550316 550317 550320 550321 550322 550323 550325 550326 550327 550328 550329 550330 550331 550333 550334 550335 550336 550337 550339 550344 550345 550346 550347 550348 550349 550350 550351 550352 550353 550354 550356 550357 550358 550359 550360 550361 550362 550363 550366 550367 550368 550369 550370…
FDA’s list runs to 19,936 characters. The first part is shown; the rest is on FDA’s record.
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: US (nationwide) and countries of: Algeria, Andorra, Argentina, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Faroe Islands, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kosovo, Kuwait, Latvia, Liechtenstein, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Norway, Oman, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay, Vietnam, and Zimbabwe.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Jan 19, 2022.
- FDA classified it on Mar 11, 2022.
- FDA’s Enforcement Report published it on Mar 23, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Medical Solutions USA, Inc., of Issaquah, WA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Other.
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.”
- FDA’s list of codes runs to 19,936 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.