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Lower risk Medical device recall · FDA · Published July 13, 2023

Siemens ACUSON Redwood 2.0 Ultrasound Systems May Show Underestimated Measurements

Siemens recalls ACUSON Redwood 2.0 ultrasound systems with software version VA20. Using an 18L6 transducer from a 1.0 system with a 2.0 system may cause underestimated measurements in Dual view, risking misdiagnosis.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2582-2023Medical deviceSiemens ›
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Contact the company

Recalling firmSiemens Medical Solutions USA, Inc.22010 Se 51st St · Issaquah, WA 98029-7298
✎ GovInfoNow plain-language explainer

Siemens is recalling ACUSON Redwood 2.0 ultrasound systems with software version VA20. Using an 18L6 transducer created on a 1.0 system with a 2.0 system can cause the device to show underestimated measurements in Dual view mode, potentially leading to misdiagnosis. Read more at govinfonow.com/recall/57655-siemens-acuson-redwood-2-0-ultrasound-systems-may-show-underestimated.

Source Summary by GovInfoNow · govinfonow.com/recall/57655-siemens-acuson-redwood-2-0-ultrasound-systems-may-show-underestimated · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2582-2023

Cite this page

“Siemens ACUSON Redwood 2.0 Ultrasound Systems May Show Underestimated Measurements.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57655-siemens-acuson-redwood-2-0-ultrasound-systems-may-show-underestimated. Based on FDA recall #Z-2582-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2582-2023%22&limit=1).

The FDA announced on July 13, 2023, that Siemens Medical Solutions USA, Inc. is recalling ACUSON Redwood 2.0 ultrasound systems due to a software error causing underestimated measurements. This defect may lead to misdiagnosis or negative patient management decisions. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Siemens
  • Product: ACUSON Redwood 2.0 ultrasound systems
  • REF: 11503314
  • UDI-DI: 04056869251264
  • Software version prefix: VA20

The hazard

If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 system, the device displays underestimated measurement results in Dual format visualization. This error may lead to misdiagnosis of a patient's condition or influence patient management decisions negatively.

Context

GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Other recent recalls include the Siemens ARTIS icono Ceiling Monitor recall for loose screws (June 8, 2026) and the Siemens ARTIS Icono Biplane recall for movement loss risk (May 20, 2026). A March 12, 2026 recall of Siemens ARTIS Pheno VE30A/VE40A units cited risks of inaccurate 3D scans due to radiation exposure.

How to tell if you have this one

Check for ACUSON Redwood 2.0 ultrasound systems with software version prefix VA20. The UDI-DI number is 04056869251264.

  • Brand
    Siemens
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify the software version prefix on your ACUSON Redwood 2.0 system; it should be VA20.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 26 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: nationwideKSArkansas: named in the noticeARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide - US Nationwide distribution including in the states of IL, WI, CA, NM, TX, NC, MI, MD, NY, OH, IN, NE, PA, LA, SC, MO, OK, VA, ME, AZ, PR, IA, NH, NJ, AR, FL, SD and the countries of GR, ES, SG, TH, KR, IN, DE, TR, AT, IT, AU,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Arkansas, California, Florida, Illinois, Indiana, Iowa, Louisiana, Maine, Maryland, Michigan, Missouri, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Texas, Virginia, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Jul 13, 202312. FDA classified it Class II: Sep 13, 202323. Published in FDA’s Enforcement Report: Sep 20, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2582-2023 (July 13, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2582-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA