Siemens recalls ACUSON NX3 ultrasound systems with specific software versions due to potential transducer acoustic output power exceeding safety limits. Affected units may require software updates or corrective actions to prevent safety risks.
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 NX3 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 harm during medical 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 safe acoustic output power limits defined for medical use, potentially causing harm during imaging procedures.
Healthcare providers using the ACUSON NX3 ultrasound systems with specific software versions are most at risk. Patients undergoing imaging with these systems may also be affected if the device malfunctions.
Check for the ACUSON NX3 model # 11235612 with software versions VA10A through VA10F and VB20A through VB20B. The recall applies to units sold with these specific software versions.
Verify the software version on your ACUSON NX3 system to see if it is one of the affected versions (VA10A through VA10F or VB20A through VB20B).
Reach out to Siemens Medical Solutions USA, Inc. for guidance on corrective actions or software updates.
The affected software versions are VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B.
Check the software version on your device; if it matches the affected versions listed (VA10A through VA10F or VB20A through VB20B), it is affected.
Contact Siemens Medical Solutions USA, Inc. for instructions 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-2352-2019 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-2352-2019 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.
