FDA-Device2023-09-20Class II
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
Siemens Medical Solutions USA, Inc.
Hazard
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.
Sold states
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.
Affected count
796
Manufactured in
22010 Se 51st St, Issaquah, WA, United States
Products
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2582-2023Don't want to check this manually?
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