Siemens recalls ACUSON Redwood 1.0 ultrasound systems with software VA10A to VA10G due to potential misdiagnosis from incorrect cardiac measurement display. Affected units have specific serial numbers listed in the recall.
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
Siemens is recalling ACUSON Redwood 1.0 diagnostic ultrasound systems with software versions VA10A through VA10G. The software may display the last measured cardiac value instead of minimum or maximum values when exporting results, which could lead to incorrect patient diagnoses or treatment decisions.
When the Cardiac DICOM SR feature is configured to show minimum or maximum cardiac measurements and multiple regions are scanned, the system may display only the last measured value instead of the full range. This could lead to misdiagnosis or inappropriate treatment decisions for patients.
Healthcare professionals using the ACUSON Redwood 1.0 ultrasound system with software versions VA10A to VA10G are most at risk. Patients receiving scans from these systems could potentially receive incorrect cardiac measurements.
Check if your ACUSON Redwood 1.0 ultrasound system has a serial number listed in the provided list (e.g., 560821, 560366, etc.) and software version VA10A to VA10G.
Verify your system's software version by checking the device settings or documentation. If it's VA10A to VA10G, it's affected.
The recall is for potential misdiagnosis risk, not immediate danger. The software issue could lead to incorrect cardiac measurements, but it does not cause physical harm directly.
Check if your ACUSON Redwood 1.0 system has a serial number listed in the provided list and software version VA10A to VA10G.
Check your software version. If it's VA10A to VA10G, contact Siemens for guidance on next steps.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1600-2024 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1600-2024 from Siemens. 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.
