Siemens Healthineers recalls SOMATOM Confidence CT scanners with model 10590100 that may abort scans when using Dual Spiral Dual Energy mode due to a software issue in syngo CT VB10A. Affected units have specific serial numbers.
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 Confidence CT scanners with model number 10590100 that may cause scans to abort when using the optional Dual Spiral Dual Energy mode. This issue stems from a software problem in the syngo CT VB10A system, which could lead to incomplete medical imaging.
The software issue in syngo CT VB10A can cause scans to abort when using the optional Dual Spiral Dual Energy mode. This may result in incomplete medical imaging, requiring additional scans or potentially delaying diagnosis.
Healthcare facilities using Siemens SOMATOM Confidence CT scanners with model number 10590100 are likely affected. Patients undergoing scans with these systems may be at risk of incomplete imaging if the software issue occurs.
Check for the model number 10590100 on the scanner. Affected units have specific serial numbers listed in the recall notice, including 122022, 100143, and other numbers provided in the record.
Verify the model number on your Siemens SOMATOM Confidence scanner. The affected model is 10590100.
If using the optional Dual Spiral Dual Energy mode, monitor for scan aborts during imaging procedures.
The recall is due to a software issue in syngo CT VB10A that may cause scans to abort when using the optional Dual Spiral Dual Energy mode.
Check the model number and serial numbers listed in the recall notice. If affected, monitor for scan aborts when using the Dual Spiral Dual Energy mode.
The issue may cause scans to abort, potentially leading to incomplete imaging, but does not pose a direct risk of injury to patients or staff.
We’ve drafted a message you can send Siemens Healthineers to request your refund or repair — edit it as you like.
Subject: Recall Z-1244-2019 — Siemens Healthineers Siemens Healthineers Hello, I own a Siemens Healthineers that is covered by recall Z-1244-2019 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.
