Siemens Medical Solutions recalls certain SOMATOM Definition AS CT scanners due to a software issue in the CARE Dose4D algorithm that may cause unnecessary radiation exposure. Affected units have serial numbers listed in the recall notice.
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 CT scanners (SOMATOM Definition AS, DS, Edge, Flash, and Force) because a software issue in the CARE Dose4D algorithm could lead to unnecessary radiation exposure during scans. This means patients and staff might receive more radiation than intended, though the risk is not immediate or severe.
The CARE Dose4D algorithm, which helps manage radiation doses in CT scans, has a software issue that may cause the scanner to deliver more radiation than intended. This could result in higher radiation exposure for patients and staff during scans, though the risk is not immediate or severe.
Healthcare facilities that own or use the recalled CT scanners, particularly those with the specific serial numbers listed in the recall notice. Patients and staff are at risk of unnecessary radiation exposure during scans.
The recalled CT scanners are models SOMATOM Definition AS, DS, Edge, Flash, and Force with specific serial numbers listed in the recall notice (e.g., 96278, 64789, etc.).
Verify if your CT scanner has a serial number listed in the provided recall notice.
Check if your scanner's serial number is listed in the recall notice (e.g., 96278, 64789, etc.).
The CARE Dose4D algorithm may deliver more radiation than intended during scans, potentially increasing exposure for patients and staff.
No action is needed if your scanner's serial number is not listed in the recall notice.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1745-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1745-2018 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.
