Z-2582-2023Class II

ACUSON Redwood 2.0 ultrasound systems, REF: 11503314

Name: Z-2582-2023 ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
Creator: Siemens Medical Solutions USA, Inc.
Published: 2023-07-13
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2023-07-13 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of ACUSON Redwood 2.0 ultrasound systems, REF: 11503314 on 2023-07-13. FDA classified it as Class II and gives the reason as "If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2582-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-13
Posted: 2023-09-13
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6 transducer and viewing in the Dual format visualization function, which may lead to misdiagnosis of a patient's condition or influence patient management decisions in a negative way.
Root cause tag: software
FDA root cause: Software design
Action: On 7/13/23, correction notices were emailed, mailed, or delivered to customers who were asked to do the following: What if I imported my user-generated presets of an 18L6 transducer from an ACUSON Redwood 1.0 system onto an ACUSON Redwood 2.0 system, then used an 18L6 transducer with Dual format to perform patient examinations using my ACUSON Redwood 2.0 system? Review any ultrasound examination results obtained in this situation. Only measurements taken from an 18L6 transducer within Dual format on ACUSON Redwood 2.0 systems are impacted. Ensure that all users of affected ultrasound systems within your organization, and others who may need to be informed, receive the relevant safety information provided with this notice and take the actions specified herein. Your Customer Service Engineer will contact you to schedule a facility visit to update the system or inform you of a remote update when the software update is available. The software update is currently under development and estimated to be available by fall of 2023. Customers with additional questions can contact customer service at 1-800-888-7436.
Quantity in commerce: 796
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, JP, FR, CA, PT, SK, BR, SA, GB, NZ, RO, SE, AE, CN, HR, PL, CH, CR, IQ, NL, MX, ZA, BO, PH, MA, PA, EG, FJ, JO, DZ, TW, DK, CZ, CO, UG, CL, VN, CM, BG, QA, AZ, EC, KW, MY, PE, GG, SV, FO, ID, NP, BA, IL, LT, DO, IE.
Product codes and lots: UDI-DI: 04056869251264. Systems with software version prefix VA20.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2582-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2582-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-20	2023-09-13

Product code IYN

K210743Class IIACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. / cleared 2021-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)