Siemens recalls Multitom RAX with software version VF10 due to potential image misalignment and dose calculation errors. Affected units may show incorrect imaging or dose warnings.
Siemens identified two issues, In some cases, it is possible to perform an image acquisition although more than 20% of the beam does not hit the detector. This may only occur when an organ program for the wall mode without top alignment is selected and the system is moved to the centred position. If afterwards the operator activates the top alignment, increases the collimation, and lifts the tube, the system allows examination even with the tube being misaligned to the detector position. Hence, it is possible to overshoot the detector by more than 20%. From a clinical point of view, it is highly unlikely for the operator to trigger the examination as the misalignment is visible due to the light field being out of range. AND In very rare cases it may occur that the calculated dose value exceeds the limit of 2 Gy. This may potentially occur only when an organ program for free exposure is selected, and the system uses incorrect (too small) source-to-image distance (SID) for calculating applied dose. Hence, the calculated dose is much higher than the actual applied dose causing the buzzer, which normally notifies the operator about the exceeded limit of 2 Gy, to get activated erroneously.
Siemens is recalling Multitom RAX CT scanners with software version VF10 because of two issues: the system might misalign the X-ray beam by more than 20% during scans, and it could incorrectly calculate radiation doses, triggering warnings. These problems are unlikely to cause harm in normal use but could lead to inaccurate images or unnecessary radiation alerts.
The scanner might misalign the X-ray beam by more than 20% if specific settings are used and the system is moved to a centered position. This could cause images to be taken incorrectly. Additionally, the system might incorrectly calculate radiation doses, triggering warnings even when no actual overexposure occurs.
Medical facilities using Siemens Multitom RAX CT scanners with software version VF10 are likely affected. Patients and staff are at minimal risk as the issues are unlikely to occur during routine operations.
Check for Siemens Multitom RAX CT scanners with software version VF10. The model number 10860700 is associated with this recall.
Verify the software version on your Siemens Multitom RAX scanner. If it is VF10, it is affected.
The recall indicates potential image misalignment and dose calculation errors, but these issues are highly unlikely to cause harm in normal use.
Check for Siemens Multitom RAX with software version VF10, specifically model number 10860700.
The recall does not specify a remedy, so no action is required beyond checking the software version.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1685-2021 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1685-2021 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.
