Siemens recalls SOMATOM Confidence CT scanners with specific serial numbers due to software version VB20_SP5 causing potential patient misdiagnosis. Affected units may need software update to prevent imaging errors.
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Siemens is recalling certain SOMATOM Confidence CT scanners because a specific software version (VB20_SP5) can lead to poor head image quality, potentially causing misdiagnosis. This affects patient safety and requires correction to ensure accurate medical imaging.
The software version VB20_SP5 causes degradation in head image quality, which could lead to misdiagnosis if the images are not accurate. This is a technical issue with the imaging software that affects diagnostic precision.
Patients using the recalled CT scanners may face misdiagnosis risks. Healthcare providers who own or operate these specific models are most at risk.
Check if your SOMATOM Confidence CT scanner has the serial numbers listed in the recall notice (e.g., 100172, 100091, etc.). The device also has a unique identifier (UDI) starting with UDI 04056869011011.
Verify your CT scanner's software version is not VB20_SP5 by contacting Siemens directly.
The software version VB20_SP5 is identified as causing potential head image quality degradation.
Check the serial numbers listed in the recall notice (e.g., 100172, 100091) or the unique identifier (UDI) starting with UDI 04056869011011.
No, the recall does not require immediate discontinuation. Users should check the software version and contact Siemens for updates if needed.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-0472-2022 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-0472-2022 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.