Recall Z-2582-2023— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-2582-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-13

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2023-07-13. It names one FDA 510(k) clearance: K210743. Product: ACUSON Redwood 2.0 ultrasound systems, REF: 11503314. Reason: 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..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-07-13
Firm location: Issaquah, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K210743 — ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.·cleared 2021-04-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.