Siemens Medical Solutions recalls SOMATOM Definition Edge CT scanners (model 10590000) due to a software issue in the CARE Dose4D algorithm that may cause unnecessary radiation exposure during scans.
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 its SOMATOM Definition Edge CT scanners (model 10590000) because a software issue in the CARE Dose4D algorithm could lead to unnecessary radiation exposure during medical imaging. This affects patients and healthcare providers who use these scanners for diagnostic imaging.
The CARE Dose4D algorithm in these CT scanners has a software issue that could cause the machine to deliver more radiation than intended during certain scans. This increases the risk of unnecessary radiation exposure for patients, though the risk is not severe enough to cause immediate harm.
Healthcare facilities using Siemens SOMATOM Definition Edge CT scanners (model 10590000) are affected. Patients undergoing scans with these machines may receive unnecessary radiation exposure.
Check for the model number 10590000 on the scanner's label. Serial numbers listed in the recall include 83249, 83277, and other numbers provided in the official notice.
Verify the model number on your Siemens SOMATOM Definition Edge scanner; the affected model is 10590000.
Reach out to Siemens Medical Solutions USA, Inc for further instructions on how to address the software issue.
If your scanner has the model number 10590000 and a serial number listed in the recall (e.g., 83249, 83277), it is affected.
The CARE Dose4D algorithm in the scanner may deliver more radiation than intended during certain scans, increasing the risk of unnecessary exposure for patients.
Contact Siemens Medical Solutions USA, Inc directly for specific instructions on addressing the software issue.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1746-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1746-2018 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.
