Lower risk Medical device recall · FDA · Published April 20, 2021

Siemens Multitom RAX Software VF10 Recall: Image Misalignment Risk

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1685-2021Medical device Siemens ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/62763-siemens-multitom-rax-software-vf10-recall-image-misalignment-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/62763-siemens-multitom-rax-software-vf10-recall-image-misalignment-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1685-2021

Cite this page

“Siemens Multitom RAX Software VF10 Recall: Image Misalignment Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62763-siemens-multitom-rax-software-vf10-recall-image-misalignment-risk. Based on FDA recall #Z-1685-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1685-2021%22&limit=1).

The FDA announced on April 20, 2021, that Siemens Medical Solutions USA, Inc. is recalling Multitom RAX units with software version VF10 due to potential radiation exposure errors. The agency mandated the recall of 26 devices distributed nationwide.

How to tell if you have it

Brand: Siemens
Product: Multitom RAX
Software version: VF10
Model number: 10860700

The hazard

Siemens stated that the system may allow image acquisition when more than 20% of the beam misses the detector, potentially causing overshoot. In very rare cases, the calculated dose value may exceed the limit of 2 Gy due to incorrect source-to-image distance calculations, causing the buzzer to activate erroneously.

Context

GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Recent similar recalls include the Siemens ARTIS icono Ceiling Monitor Recall (June 8, 2026), the Siemens ARTIS icono floor recall (May 20, 2026), and the Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026). Other recent recalls of similar products include Philips Ingenuity CT Scanners (August 7, 2026), Philips Brilliance CT 64 Medical Scanner Recall (August 7, 2026), and Philips IQon Spectral CT Software 4.7.7.x Recall (August 7, 2026).

How to tell if you have this one

Check for Siemens Multitom RAX CT scanners with software version VF10. The model number 10860700 is associated with this recall.

Brand
Siemens
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify the software version on your Siemens Multitom RAX scanner. If it is VF10, it is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

Apr 20, 2021Firm started the recall
Jun 2, 2021FDA classified it Class II
Jun 9, 2021Published in FDA’s Enforcement Report
Nov 8, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/62763-siemens-multitom-rax-software-vf10-recall-image-misalignment-risk">Siemens Multitom RAX Software VF10 Recall: Image Misalignment Risk (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1685-2021 (April 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1685-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.