Siemens recalls SOMATOM Perspective X-ray scanners due to rare risk of incorrect radiation dose calculations for head scans, potentially causing unnecessary exposure. Affected units may need evaluation by a qualified professional.
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 X-ray scanners because a software algorithm might calculate incorrect radiation doses for head scans in rare cases, leading to unnecessary radiation exposure. This could pose a risk to patients receiving head scans.
The CARE Dose4D algorithm used in head scans might miscalculate radiation doses based on skull geometry. In rare cases, this could result in unnecessary radiation exposure for patients, though the risk is very low.
Patients undergoing head scans with the SOMATOM Perspective scanner may be at risk if the scanner calculates incorrect radiation doses. Healthcare providers using the device for medical imaging are most affected.
Check if you own a Siemens SOMATOM Perspective scanner used for producing cross-section body images via X-ray. The product was sold with the model number 10046733.
Reach out to Siemens Medical Solutions USA, Inc for guidance on whether your scanner needs evaluation.
The recall indicates a rare risk of incorrect radiation dose calculations for head scans, but the hazard is very low and not expected to cause serious injury.
Check if your scanner is a Siemens SOMATOM Perspective model with the product number 10046733.
No, the recall does not require immediate discontinuation. Contact Siemens for evaluation if you have the affected scanner.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1447-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1447-2018 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.
