ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
Reported: September 20, 2023 Initiated: July 13, 2023 #Z-2582-2023
Product Description
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc.
- Units Affected
- 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.
- Location
- Issaquah, WA
Frequently Asked Questions
What product was recalled? ▼
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 796.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 20, 2023. Severity: Moderate. Recall number: Z-2582-2023.
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