Siemens recalls ACUSON NX2 ultrasound systems with specific software versions due to potential transducer acoustic output power exceeding safety limits. Affected units may require software updates or corrective action to prevent unintended acoustic output.
The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not loaded correctly into hardware
Siemens is recalling ACUSON NX2 diagnostic ultrasound systems with certain software versions because internal testing found a risk of transducers exceeding safe acoustic output power levels. This could potentially cause unintended acoustic output that might affect patient safety during imaging procedures.
The software issue causes transducers to calculate transit voltage values for PW Doppler but not load them correctly into hardware. This could lead to transducers exceeding the acoustic output power (AOP) limits defined for safe medical use. The risk is related to potential unintended acoustic output during imaging procedures.
Healthcare professionals using the ACUSON NX2 ultrasound systems with specific software versions (VA10A, VA10B, VA11A, VA11B) are most at risk. Patients undergoing imaging with these systems may also be affected if the transducers exceed safe acoustic output levels.
Check for the ACUSON NX2 model # 11284381 with software versions VA10A, VA10B, VA11A, or VA11B. The unique device identifier (UDI) starts with 04056869030005. These units were sold for cardiac, fetal, abdominal, and other medical imaging applications.
Verify the software version on your ACUSON NX2 system; affected versions are VA10A, VA10B, VA11A, or VA11B.
Reach out to Siemens Medical Solutions for guidance on corrective actions or software updates.
The affected software versions are VA10A, VA10B, VA11A, and VA11B.
Check for the model number 11284381 with software versions VA10A, VA10B, VA11A, or VA11B. The unique device identifier (UDI) starts with 04056869030005.
Contact Siemens Medical Solutions for guidance on corrective actions or software updates.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-2350-2019 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-2350-2019 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.
