ACUSON Redwood 1.0 Diagnostic Ultrasound System
Medical device recall Z-1600-2024. 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
- 628 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 Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
628, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 04056869251264. Serial Numbers: 560821 560366 560250 560251 560311 560490 560489 560069 560207 560107 560055 560051 560801 560478 560450 560379 560349 560152 561113 561137 560474 560598 560672 560674 560603 561007 560587 560284…
Every code shown here, 2,000 characters
UDI-DI: 04056869251264. Serial Numbers: 560821 560366 560250 560251 560311 560490 560489 560069 560207 560107 560055 560051 560801 560478 560450 560379 560349 560152 561113 561137 560474 560598 560672 560674 560603 561007 560587 560284 561272 560553 560639 561024 561025 561274 560746 560747 562194 561279 561326 562155 562161 562199 562141 562146 562195 562160 562211 562147 560514 562051 560552 562124 560883 562128 560875 562066 560498 562061 562037 562052 562038 562024 561452 562003 561472 561354 561386 561465 561466 561467 560512 560656 561395 560554 561391 561271 561317 561315 561347 561273 561287 560756 561235 560777 561263 561264 561262 561224 560872 560802 560887 560888 560882 560881 561213 560810 560739 560741 560755 560754 560785 561164 560886 560779 560884 561047 560885 561045 560880 560791 560620 560551 561021 561081 561034 561035 560510 560869 560792 561043 561046 561040 561048 561027 561029 561037 560776 560650 561006 560508 560752 560804 560835 561003 560641 560649 560855 560856 560805 560813 560814 560809 560763 560783 560767 560769 560770 560774 560793 560661 560794 560696 560738 560740 560635 560703 560692 560530 560582 560632 560634 560596 560606 560622 560610 560516 560589 560513 560525 560533 560507 560515 560266 560522 561309 560188 560657 560837 560612 561166 561167 560216 560834 560651 560652 560654 560426 560270 560123 560108 561015 561001 560168 561285 560280 560682 560753 560762 560710 560636 560644 560633 560535 560062 560472 560473 560427 560428 560323 560388 560369 560324 560293 560233 560294 560153 560219 560166 560154 560125 560140 560087 560013 560151 560669 560646 560531 561217 561099 561143 560443 561010 560860 560830 560183 560751 560668 560067 560015 560014 560619 560576 560420 560116 560393 560386 560331 560282 560194 560137 560138 560096 560145 560009 560217 560401 560575 561312 561261 560714 560812 560745 560697 560695 560613 560020 560563 560564 560500 560464 560334 560338 560326 560327 560272 560263 560265 560261 560256 560258…
FDA’s list runs to 4,050 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 4,050 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.