Siemens recalls SOMATOM Sensation 16 CT scanners that may calculate incorrect radiation doses for head scans, potentially causing unnecessary exposure. Affected units sold from 2015-2: contact Siemens for details.
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 16 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 undergoing head scans with the device.
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 scans with the SOMATOM Sensation 16 CT scanner are most at risk. The recall affects units sold from 2015 through 2022.
Check for the model number 7393114 on the scanner. The SOMATOM Sensation 16 was sold from 2015 through 2022.
Siemens Medical Solutions USA, Inc. will provide details about the recall and any necessary actions.
The recall indicates a rare possibility of unnecessary radiation exposure, but it is not a serious hazard.
Check for the model number 7393114 on the scanner. The SOMATOM Sensation 16 was sold from 2015 through 2022.
Contact Siemens Medical Solutions USA, Inc. for details about the recall and any necessary actions.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1454-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1454-2018 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.
