ACUSON Juniper Diagnostic Ultrasound System
Medical device recall Z-1599-2024. Published in FDA’s Enforcement Report on May 1, 2024.
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 May 1, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 40 states named
- 5090 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?
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C
5090, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
REF/UDI-DI: 11335791/04056869152059, and 11653093/04056869957357. Serial Numbers: 571063 556506 555717 555502 555450 555448 552655 552659 550763 556982 556990 556996 556998 557000 557001 557002 557003 555641 555631 553876 553877 556233…
Every code shown here, 2,000 characters
REF/UDI-DI: 11335791/04056869152059, and 11653093/04056869957357. Serial Numbers: 571063 556506 555717 555502 555450 555448 552655 552659 550763 556982 556990 556996 556998 557000 557001 557002 557003 555641 555631 553876 553877 556233 557117 557122 557123 556083 556082 556080 556081 556043 556044 556045 556046 556047 555714 555285 555281 555282 555283 555286 555287 555288 555290 555289 555284 550462 550460 550461 550915 550878 573362 573314 570015 573313 573132 570258 570332 575056 570033 556390 556738 556734 556545 555666 555746 552723 553173 552986 553174 550198 550541 550310 550214 550052 550051 573202 575041 571545 570335 570288 570227 575050 575051 556510 575011 570057 570058 570028 556973 557069 556967 556974 556920 555875 556598 556514 556399 556004 555693 555107 555719 555545 555477 555429 555197 555167 555215 555144 555124 555155 553043 553161 552998 553829 553542 553435 555033 553437 553438 553302 552775 551895 551967 551970 550940 555364 555368 555622 555966 556295 556334 556462 556463 556464 556490 556724 556727 556735 556812 556885 557057 557063 557068 557127 557306 557393 570031 570118 570196 571568 573178 573343 573439 576207 576231 576245 578060 557401 557372 555951 573052 555729 557113 556508 556052 555514 555530 555166 570067 573422 578089 573392 573393 570174 573044 570066 556783 556784 556650 555611 556358 556008 556030 555109 555985 555100 555121 555793 555701 555625 555544 555390 555202 555171 552907 553037 552729 553468 552594 552937 551775 550993 550834 550294 550038 556557 556271 555967 555607 555311 552708 551574 550029 557114 557252 557364 557370 555671 550775 570349 557300 570379 570357 570364 570373 570381 557299 572027 576011 576012 570384 570351 570359 570367 570368 570387 570389 570358 570391 570352 570366 570378 570386 570388 570390 570218 570338 570353 570365 570377 570382 570383 570348 570354 570355 570356 570362 570363 570371 570372 570374 570375 570380 556997 557294 570350 570341 557292 557293 557014 557015 557239 557240 557238…
FDA’s list runs to 33,599 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 including in the states of AL, AR, CA, CO , CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA , MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WY and the countries of BG, BW, BA, TR, AR, CL, CN, FR, SK, CD, BH, PH, AM, CR, AF, BE, AE, AZ, AO, KR, RO, HU, HR, DK, AU, DZ, CY, PL, BO, AL, NL, CI, BR, CZ, DE, AT, ES, CO, BD, CH, IT, CA, CM, DO, EC, EG, ER, ET, FI, FO, GB, GE, GR, GT, GY, HK, HN, ID, IE, IL, IN, IQ, IR, JO, JP, KE, KW, KZ, LB, LT, LU, LV, LY, MA, MD, ME, MK, MM, MN, MU, MW, MX, MY, NG, NO, NP, NZ, OM, PA, PE, PG, PK, PT, PY, QA, RS, RU, SA, SE, SG, SI, SM, SN, SV, SZ, TH, TN, TT, TW, TZ, UA, UG, UY, UZ, VN, XK, YE, ZA, ZM, ZW.
The states and territories these words name
40 states and territories.
Every one of them
- Alabama
- Arkansas
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Hawaii
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- New Mexico
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- Wyoming
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 Feb 23, 2024.
- FDA classified it on Apr 19, 2024.
- FDA’s Enforcement Report published it on May 1, 2024.
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: 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.”
- FDA’s list of codes runs to 33,599 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.