Z-2582-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2023
- Initiation Date
- July 13, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 796
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.
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.
Code Information
UDI-DI: 04056869251264. Systems with software version prefix VA20.