Siemens recalls SOMATOM Perspective 16 CT scanners that may calculate incorrect radiation doses for head scans, potentially causing unnecessary exposure. Affected units 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 Perspective 16 CT scanners because a software algorithm might calculate incorrect radiation doses for head scans, leading to unnecessary radiation exposure in rare cases. This could affect patients undergoing head imaging.
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 depending on skull geometry, though it only happens rarely.
Patients undergoing head CT scans using the recalled scanner model are most at risk. The recall applies to specific units sold with model number 10046734.
Check if your scanner has model number 1004:6734. The device is intended for producing cross-section images of the body using x-ray data.
Look for model number 10046734 on the scanner.
The recall indicates a rare possibility of unnecessary radiation exposure, but it does not cause serious injury or death.
Check for model number 10046734 on the scanner.
The recall does not require immediate action; check the model number and contact Siemens if needed.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1448-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1448-2018 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.
