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Open, Classified

ACUSON Redwood 2.0 ultrasound systems, REF: 11503314

FDA Recall Z-2582-2023 · Posted 2023-09-13

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusOpen, Classified
Product CodeIYN
Date Initiated2023-07-13
Product Quantity796

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.

Firm Action

On 7/13/23, correction notices were emailed, mailed, or delivered to customers who were asked to do the following: What if I imported my user-generated presets of an 18L6 transducer from an ACUSON Redwood 1.0 system onto an ACUSON Redwood 2.0 system, then used an 18L6 transducer with Dual format to perform patient examinations using my ACUSON Redwood 2.0 system? Review any ultrasound examination results obtained in this situation. Only measurements taken from an 18L6 transducer within Dual format on ACUSON Redwood 2.0 systems are impacted. Ensure that all users of affected ultrasound systems within your organization, and others who may need to be informed, receive the relevant safety information provided with this notice and take the actions specified herein. Your Customer Service Engineer will contact you to schedule a facility visit to update the system or inform you of a remote update when the software update is available. The software update is currently under development and estimated to be available by fall of 2023. Customers with additional questions can contact customer service at 1-800-888-7436.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2021-04-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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