Recall of Siemens ACUSON Sequoia ultrasound systems with software version VA25A/B due to measurement error in 2D trace tool potentially causing misdiagnosis. Affected units have specific serial numbers listed.
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.
Siemens is recalling ACUSON Sequoia ultrasound imaging systems with software version VA25A/B because a calculation error in the 2D trace tool may overestimate the circumference of measurements, leading to potential misdiagnosis of patient conditions. This recall affects specific units with listed serial numbers.
The software version VA25A/B contains a calculation error in the 2D trace (manual trace) tool. This error causes the traced circumference value to be overestimated, which could lead to incorrect patient diagnoses if the ultrasound measurements are used for medical decisions.
Healthcare providers using the ACUSON Sequoia ultrasound system with software version VA25A/B are likely affected. Patients receiving ultrasounds from these systems may be at risk of misdiagnosis due to inaccurate measurements.
Check if your ACUSON Sequoia ultrasound system has software version VA25A/B. Affected units have specific serial numbers listed in the recall notice, including 800101 through 802999.
Verify your system's software version by checking the device settings or documentation. If it is VA25A/B, it is affected.
The recall indicates a potential risk of misdiagnosis due to measurement errors in the software, but it does not involve immediate physical harm. The risk is low and specific to the software version.
Check your system's serial number against the list of affected units provided in the recall notice, which includes serial numbers from 800101 to 802999.
No action is required if your system has a different software version or a serial number not listed in the recall.
We’ve drafted a message you can send Siemens Medical Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-0547-2022 — Siemens Medical Solutions Siemens Medical Solutions Hello, I own a Siemens Medical Solutions that is covered by recall Z-0547-2022 from Siemens Medical Solutions. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
