Recall Z-0547-2022— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-0547-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-12

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2021-11-12. It names one FDA 510(k) clearance: K201462. Product: ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B. Reason: Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient's condition..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-11-12
Firm location: Issaquah, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K201462 — ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.·cleared 2020-06-24

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 Sequoia Ultrasound Imaging System with Software Version VA25A/B

Reason for recall

Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient's condition.

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