Siemens recalls specific model SOMATOM Edge Plus CT scanners due to software version VB20_SP5 causing potential patient misdiagnosis. Affected units have serial numbers listed in the recall notice.
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 Edge Plus CT scanners that may cause misdiagnosis due to a software issue. This could lead to incorrect medical decisions for patients if the scanner is used without the fix.
The software version VB20_SP5 can degrade head image quality, which might lead to misdiagnosis. This means medical professionals could make incorrect treatment decisions based on flawed scan results.
Healthcare facilities using the specific model 1026700 with listed serial numbers are most at risk. Patients receiving scans on these units may face potential misdiagnosis.
Check if your scanner has the model number 1026700 and serial numbers listed in the recall notice. The unique device identifier (UDI) is 04056869006949.
Identify if your scanner has the model number 1026700 and the listed serial numbers.
The recall is for healthcare facilities using the scanner. Patients may be affected if they receive scans on affected units, but the recall does not specify direct patient impact.
The software version VB20_SP5 is identified as causing potential image quality degradation.
Check the serial number against the list provided in the recall notice or verify the unique device identifier (UDI) is 04056869006949.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-0474-2022 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-0474-2022 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.
