Siemens recalls ACUSON Maple and Maple Select ultrasound systems with software version VA10A due to potential misdiagnosis of cardiac measurements when exporting results.
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 Maple and Maple Select ultrasound systems with software version VA10A. This could lead to incorrect cardiac measurements being displayed, which might affect patient care decisions.
When the Cardiac DICOM SR feature is set 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 incorrect patient management decisions if the wrong measurement is used.
Healthcare providers using these ultrasound systems for cardiac imaging are most at risk. Patients receiving scans with the affected software may experience potential misdiagnosis.
Check for serial numbers listed in the recall notice: 700127, 700125, 700109, and other numbers provided in the record. The affected systems run software version VA10A.
Verify the software version on your ACUSON Maple or Maple Select system; affected units run version VA10A.
The affected software version is VA10A.
Check your serial number against the list provided in the recall notice, which includes numbers like 700127 and 700109.
The recall record does not mention a remedy or fix.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1601-2024 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1601-2024 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.
