Siemens recalls certain SOMATOM Definition Edge CT scanners with software version VB20_SP5 that may cause misdiagnosis due to degraded head image quality. Affected units have specific serial numbers.
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Siemens is recalling some SOMATOM Definition Edge CT scanners that have a software version (VB20_SP5) which might cause head images to be degraded, potentially leading to misdiagnosis. This recall affects specific models with listed serial numbers.
The software version VB20_SP5 can cause head images to degrade in quality, which might lead to misdiagnosis. This is a potential risk to patients but does not involve immediate physical harm or failure of the device.
Healthcare facilities using the SOMATOM Definition Edge CT scanners with serial numbers listed in the recall. Patients undergoing scans on these specific units may face misdiagnosis risks.
Check if your SOMATOM Definition Edge CT scanner has the serial numbers listed in the recall (e.g., 155403, 84012, 83047, etc.). The device also has a unique identifier (UDI) starting with 04056869006949.
Verify if your scanner's serial number matches the list provided in the recall.
The software version VB20_SP5 can cause head images to degrade in quality, which might lead to misdiagnosis.
Check if your scanner's serial number is in the list provided in the recall. If it is, contact Siemens for further instructions.
The recall record does not specify a remedy, so no immediate fix is provided.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-0475-2022 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-0475-2022 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.
