The Recall Desk
HighFDA (Devices)·Z-0547-2022·Announced 2022-02-09

Ultrasound System Software Calculation Error in Siemens ACUSON Sequoia

Software error in certain Siemens ACUSON Sequoia ultrasound systems causes measurement values to be overestimated, potentially resulting in patient misdiagnosis.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II device with a software defect presenting risk of patient misdiagnosis through inaccurate measurements. No illnesses, injuries, or deaths have been reported, and the hazard remains theoretical.

Plain-English summary

Siemens Medical Solutions USA is recalling 1,161 ACUSON Sequoia Ultrasound Imaging Systems with Software Version VA25A/B due to a software calculation error affecting the 2D trace (manual trace) tool.

The error causes the trace circumference value to be overestimated during measurements. This inaccuracy could potentially lead to misdiagnosis of a patient's medical condition.

The affected systems have been distributed worldwide, including to all U.S. states. Patients and clinicians should be aware of this potential measurement error when reviewing ultrasound results. Contact Siemens Medical Solutions for information on available software corrections or other remedial measures.

The recalled product

Product
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
Manufacturer
Siemens Medical Solutions USA, Inc.
Category
Medical Device — Ultrasound System
Hazard
  • measurement-error
  • misdiagnosis-risk

Distribution

Distributed nationwide across the United States.

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