Siemens recalls SOMATOM Emotion 16 CT scanners that may calculate incorrect radiation doses for head scans, potentially causing unnecessary exposure in rare cases.
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 Emotion 16 CT scanners because a software algorithm might calculate incorrect radiation doses for head scans. This could lead to unnecessary radiation exposure in rare cases, though the risk is low.
The CARE Dose4D algorithm may calculate incorrect radiation doses for head scans based on skull geometry. In rare cases, this could result in unnecessary radiation exposure to the patient.
Patients undergoing head CT scans at facilities using the recalled scanner. Medical professionals who operate the scanner are most at risk if they use the device without correction.
The SOMATOM Emotion : 16 CT scanner with model number 10046789. This device was sold for medical use to produce cross-section images of the body.
Look for the model number 10046789 on the scanner's label or documentation.
The recall indicates a rare possibility of incorrect radiation dose calculations, but the risk of unnecessary exposure is low.
Check for the model number 10046789 on the scanner's label or documentation.
The recall does not specify a remedy, so contact Siemens directly for guidance.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1446-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1446-2018 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.
