Siemens Medical Solutions USA, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2582-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

ACUSON Redwood 2.0 ultrasound systems, REF: 11503314

Product Classification:

Class II

Date Initiated: July 13, 2023

Date Posted: September 20, 2023

Recall Number: Z-2582-2023

Event ID: 92750

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.

Status: Ongoing

Product Quantity: 796

Code Information:

UDI-DI: 04056869251264. Systems with software version prefix VA20.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated