ACUSON Redwood 2.0 ultrasound systems recall
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
Why was ACUSON Redwood 2.0 ultrasound systems 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 04056869251264. Systems with software version prefix VA20.
- Product
- ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Quantity
- 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.
- Recall date
- September 20, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)