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 64 CT scanners because a software algorithm might calculate incorrect radiation doses for head scans, potentially leading to unnecessary exposure in rare cases. This could affect patients undergoing head imaging with the scanner.
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 to patients in rare cases depending on skull geometry.
Patients undergoing head CT scans with the SOMATOM Sensation 64 scanner are most at risk. The recall applies to the scanner model used in medical facilities.
Check if your scanner model is listed as SOMATOM Sensation 64. The recall applies to scanners sold with the serial number 8377520.
Verify your scanner model is SOMATOM Sensation 64 with serial number 8377520.
The recall indicates a rare risk of unnecessary radiation exposure in specific head scans, but it is not a serious hazard for most patients.
Check if your scanner model is SOMATOM Sensation 64 with serial number 8377520.
No action is required for the scanner itself; the recall is for information about potential risks in specific scans.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1456-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1456-2018 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.
