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