Siemens recalls ACUSON NX3 Elite ultrasound systems with specific software versions due to potential transducer power exceeding safety limits. Affected units may have risks during imaging procedures.
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 Elite diagnostic ultrasound systems with certain software versions. The recall is because internal testing found a risk that transducers might exceed safe acoustic power levels during use, which could affect imaging safety.
The ultrasound system's transducers might exceed safe acoustic power levels during operation. This could happen because the software calculates transit voltage values for Doppler but doesn't load them correctly into the hardware, potentially affecting imaging safety.
Healthcare professionals using the ACUSON NX3 Elite ultrasound systems with software versions VA10A through VA10F and VB20A through VB20B are most at risk. These units were sold with specific UDI numbers.
Check for the model number 11235411 and software versions VA10A through VA10F or VB20A through VB20B. The units have a unique device identifier (UDI) starting with 04056869004303.
Review the software version on your device to see if it matches VA10A through VA10F or VB20A through VB20B.
Software versions VA10A through VA10F and VB20A through VB20B.
Check the model number 11235411 and software version. Affected units have a unique device identifier (UDI) starting with 04056869004303.
No, but you should check the software version to determine if your unit is affected.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-2353-2019 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-2353-2019 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.
