Siemens recalls SOMATOM Sensation 10 CT scanners that may calculate incorrect radiation doses for head scans, potentially causing unnecessary exposure. Affected units were sold with specific model numbers.
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 10 CT scanners because a software algorithm might incorrectly calculate radiation doses for head scans, leading to unnecessary exposure in rare cases. This could affect patients undergoing head imaging.
The CARE Dose4D algorithm may calculate incorrect radiation doses 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 immediate.
Patients undergoing head CT scans using the recalled scanner may be at risk of unnecessary radiation exposure. Healthcare providers using the device are also affected.
The recalled scanner is the Siemens SOMATOM Sensation : 7543015. It was sold for medical use to produce cross-section images of the body via x-ray.
Look for the model number 7543015 on the scanner's label or documentation.
The recall indicates a rare risk of unnecessary radiation exposure, but it is not an immediate hazard. The risk is very low and not likely to cause injury.
Check for the model number 7543015 on the scanner's label or documentation. This model was sold for medical use to produce cross-section images of the body via x-ray.
No action is required for the scanner to continue functioning safely. The risk is very low and not immediate.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1453-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1453-2018 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.
