Siemens recalls ACUSON NX2 Elite ultrasound systems with specific software versions due to potential transducer power exceeding safety limits. Affected units may have risks during use; contact for remedy.
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 Elite diagnostic ultrasound systems with certain software versions because internal testing found a risk of transducers exceeding safe acoustic output power. This could potentially cause harm during medical imaging procedures.
The ultrasound system's transducers might exceed safe acoustic output power levels during operation. This occurs because the transit voltage values for PW Doppler are calculated correctly but not properly loaded into the hardware, potentially leading to unsafe output levels.
Healthcare professionals using the ACUSON NX2 Elite ultrasound systems with specific software versions (VA10A, VA10B, VA11A, VA11B) are most at risk. Patients using these systems may also be affected if the device malfunctions.
Check for the model number 11284500 on the device. Affected units have software versions VA10A, VA10B, VA11A, or VA11B. The unique device identifier (UDI) starts with 04056869050775.
Identify the software version on your device; affected units have VA10A, VA10B, VA11A, or VA11B.
Reach out to Siemens Medical Solutions for guidance on next steps and potential remedies.
Affected software versions are VA10A, VA10B, VA11A, and VA11B.
Check for model number 11284500 and software versions VA10A, VA10B, VA11A, or VA11B. The unique device identifier (UDI) starts with 04056869050775.
The recall record does not specify a remedy, so contact Siemens for further instructions.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-2351-2019 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-2351-2019 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.
