Siemens recalls SOMATOM Scope CT scanners that may calculate incorrect radiation doses for head scans, potentially causing unnecessary exposure. Affected units sold between 2019-2:10 and 2020-03-10.
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 Scope CT scanners because a software algorithm might incorrectly calculate radiation doses for head scans, leading to unnecessary exposure in rare cases. This could mean higher radiation levels than intended for some patients.
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 for patients with specific skull geometries, though it's rare.
Patients undergoing head CT scans with the SOMATOM Scope scanner are at risk, particularly those with complex skull shapes. Healthcare facilities using the scanner may also be affected.
The SOMATOM Scope scanner is used for producing cross-section body images via x-ray reconstruction. It was sold between 2019-02-10 and 2020-03-10. Check if your scanner has the model number 10046799.
Look for the model number 10046799 on the scanner's label or documentation.
The recall indicates a rare risk of unnecessary radiation exposure for some patients with specific skull shapes, but it is not a serious hazard.
Check for the model number 10046799 on the scanner's label or documentation. The scanner was sold between 2019-02-10 and 2020-03-10.
No action is required for the scanner itself. The recall focuses on potential dose calculation errors, not immediate safety risks.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1449-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1449-2018 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.
