Siemens recalls certain SOMATOM Definition Flash CT scanners due to potential unnecessary radiation exposure from a software issue in the CARE Dose4D algorithm. Affected units have specific serial numbers.
There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force.
Siemens is recalling specific models of their SOMATOM Definition Flash CT scanners because a software issue in the CARE Dose4D algorithm could lead to unnecessary radiation exposure during scans. This affects patients and medical staff who use these scanners, as radiation exposure is a health risk.
The CARE Dose4D software algorithm in these CT scanners may not properly calculate radiation doses, potentially leading to higher than intended radiation exposure during scans. This is a software issue that could cause unnecessary radiation to be delivered to patients and medical personnel.
Patients and medical staff who use the recalled Siemens SOMATOM Definition Flash CT scanners are at risk of unnecessary radiation exposure. The risk is low but could accumulate over time with repeated scans.
Check if your scanner has the model number SOMATOM Definition Flash (10430603) and the listed serial numbers in the recall notice. The affected units were sold between 2015 and 2020.
Identify if your scanner is a SOMATOM Definition Flash (Model 10430603) with the listed serial numbers.
Reach out to Siemens Medical Solutions USA, Inc for further instructions on potential remedies.
Check if your scanner has the model number SOMATOM Definition Flash (10430603) and one of the listed serial numbers in the recall notice.
Siemens Medical Solutions USA, Inc will contact affected customers for further instructions on potential remedies.
The software issue may lead to unnecessary radiation exposure during scans, but the risk is low and depends on the number of scans performed.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1747-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1747-2018 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.
