Siemens recalls SOMATOM Sensation Open CT scanners that may calculate incorrect radiation doses for head scans, risking unnecessary exposure. Affected units sold from 2017 onward.
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
Siemens is recalling its SOMATOM Sensation Open CT scanners because a software algorithm might calculate incorrect radiation doses for head scans, potentially leading to unnecessary radiation exposure in rare cases. This could affect patients undergoing head imaging procedures.
The CARE Dose4D algorithm may miscalculate radiation doses for head scans when using posterior-anterior or anterior-posterior topograms. This could result in unnecessary radiation exposure depending on skull geometry, though it's rare.
Patients undergoing head CT scans with the recalled scanner model are most at risk. The recall applies to units sold starting in 2017.
Check for the SOMATOM Sensation Open model, which was sold starting in 2017. The product is used for CT imaging of the body via x-ray reconstruction.
Identify if your scanner is a SOMATOM Sensation Open model sold from 2017 onward.
The recall indicates a rare risk of unnecessary radiation exposure, but it's not a direct safety hazard for most users.
Check if your scanner is a SOMATOM Sensation Open model sold starting in 2017.
The recall does not specify a remedy, so contact Siemens directly for guidance.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1457-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1457-2018 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.
