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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 1,161
Distribution
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