Siemens Healthineers recalls SOMATOM Edge Plus CT scanners with serial numbers starting from 83746 that may abort scans when using Dual Spiral Dual Energy mode due to a software issue.
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 SOMATOM Edge Plus CT scanners with specific serial numbers because a software issue in the syngo CT VB10A system can cause scans to be aborted when using the 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 be aborted when using the Dual Spiral Dual Energy mode. This may result in incomplete imaging, requiring additional scans and potentially delaying critical diagnoses.
Patients and healthcare providers using Siemens SOMATOM Edge Plus CT scanners with the listed serial numbers are affected. Those performing scans in the Dual Spiral Dual Energy mode are at the highest risk of scan interruptions.
Check if your Siemens SOMATOM Edge Plus CT scanner has a serial number listed in the provided range (e.g., 83746, 100092, 122022). The product is used for generating cross-sectional images of patients via computed tomography.
Identify your scanner's serial number and compare it to the list of affected serial numbers provided in the recall notice.
Do not use the Dual Spiral Dual Energy mode on the affected scanner until the software issue is resolved.
A software issue in the syngo CT VB10A system can cause scans to be aborted when using the Dual Spiral Dual Energy mode, potentially leading to incomplete imaging.
Check your scanner's serial number against the list provided in the recall notice. Avoid using the Dual Spiral Dual Energy mode until the software issue is resolved.
The recall notice does not specify a fix or remedy; users must avoid the Dual Spiral Dual Energy mode until the issue is resolved.
We’ve drafted a message you can send Siemens Healthineers to request your refund or repair — edit it as you like.
Subject: Recall Z-1246-2019 — Siemens Healthineers Siemens Healthineers Hello, I own a Siemens Healthineers that is covered by recall Z-1246-2019 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.