Siemens Healthineers recalls SOMATOM Definition Edge CT scanners with specific serial numbers due to potential scan aborts in Dual Spiral Dual Energy mode from a software issue in syngo CT VB10A.
Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.
Siemens Healthineers is recalling certain SOMATOM Definition Edge CT scanners because a software issue in the syngo CT VB10A system may cause scans to abort when using the optional Dual Spiral Dual Energy mode. This could lead to incomplete medical imaging and potential delays in diagnosis.
The software issue in the syngo CT VB10A system can cause scans to abort when the optional Dual Spiral Dual Energy mode is used. This may result in incomplete medical imaging, requiring additional scans and potentially delaying diagnosis or treatment.
Medical facilities using the recalled SOMATOM Definition Edge CT scanners with specific serial numbers are affected. Patients undergoing scans on these systems may experience incomplete imaging if the issue occurs.
Check if your SOMATOM Definition Edge CT scanner has a serial number listed in the provided list (e.g., 122022, 100143, 100107, etc.). The product is used for generating cross-sectional images of patients via computed tomography.
Identify if your scanner has a serial number from the list provided in the recall notice.
The recall is due to a software issue in the syngo CT VB10A system that may cause scans to abort when using the optional Dual Spiral Dual Energy mode.
Check your scanner's serial number against the list provided in the recall notice. If it matches, contact Siemens Healthineers for further instructions.
This issue may cause scans to abort, potentially leading to incomplete imaging and delays in diagnosis, but it does not pose a direct risk of injury to users.
We’ve drafted a message you can send Siemens Healthineers to request your refund or repair — edit it as you like.
Subject: Recall Z-1245-2019 — Siemens Healthineers Siemens Healthineers Hello, I own a Siemens Healthineers that is covered by recall Z-1245-2019 from Siemens Healthineers. 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.
