Siemens recalls SOMATOM Sensation : Rare risk of unnecessary radiation exposure during head scans due to potential dose calculation errors in the CARE Dose4D algorithm.
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 40 CT scanners because a software algorithm might calculate incorrect radiation doses for head scans, leading to unnecessary exposure in rare cases. This could affect patients receiving head scans with this equipment.
The CARE Dose4D algorithm may calculate radiation doses incorrectly for head scans based on skull geometry. This could result in unnecessary radiation exposure in rare cases, but the risk is very low and not applicable to all scans.
Patients undergoing head scans with the SOMATOM Sensation 40 CT scanner are most at risk. Healthcare facilities using this model may also be affected.
Check for the SOMATOM Sensation 40 CT scanner model. This product was sold with the serial number 8874427.
Identify if your scanner is the SOMATOM Sensation 40 model with the serial number 8874427.
The recall indicates a rare risk of unnecessary radiation exposure in specific head scans, but the risk is very low and not applicable to all scans.
Check if your scanner is the SOMATOM Sensation 40 model with the serial number 8874427.
The recall does not specify a remedy, so no action is required beyond checking if your scanner is affected.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1458-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1458-2018 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.