Siemens recalls ACUSON SC2000 ultrasound systems that may underestimate heart blood flow measurements, affecting cardiac diagnoses. Serial numbers listed in the notice.
The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume transthoracic echocardiography transducer.
Siemens is recalling ACUSON SC2000 ultrasound systems that may provide inaccurate heart blood flow measurements. This could lead to incorrect cardiac diagnoses if used without proper verification.
The system may underestimate the effective regurgitant orifice area (EROA) in heart measurements compared to other imaging methods. This could lead to inaccurate cardiac diagnoses if not corrected.
Healthcare providers using the ACUSON SC2000 ultrasound system for cardiac imaging may be affected. Patients receiving cardiac diagnoses from this system could be at risk of incorrect treatment.
Check if your ACUSON SC2000 ultrasound system has serial numbers listed above. The system uses software versions VB10A, VB10B, VB10D, or VB10E with specific licenses.
Verify your system's serial number against the list provided in the recall notice.
The ACUSON SC2000 may underestimate heart blood flow measurements compared to other imaging methods, potentially leading to incorrect cardiac diagnoses.
Software versions VB10A, VB10B, VB10D, and VB10E with specific licenses are affected.
Check your system's serial number against the list of 400+ serial numbers provided in the recall notice.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1065-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1065-2018 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.
