09
Feb
2022

Recall – Ultrasound software overestimates trace value

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Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 2/9/2022
Class II

PRODUCT

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

Recall Number: Z-0547-2022

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/MANUFACTURER

Siemens Medical Solutions USA, Inc. on 11/12/2021. Voluntary: Firm initiated

VOLUME OF PRODUCT IN COMMERCE

1161 systems

DISTRIBUTION

U.S. Nationwide and International

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