Use cautionMedical device recall · FDA · Published August 19, 2020
Siemens RT Image Suite Software VA30_SP02 Recall: Incorrect Dose Risk
Siemens Medical Solutions recalls software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK due to potential incorrect radiation dose delivery. Affected units include specific scanner serial numbers.
Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset value is not recognized during the subsequent treatment planning process or remains undetected during the position verification at the treatment system (e.g. linear accelerator), this can potentially result in an incorrect dose or dose applied to the wrong location
Take action
Contact the company
📍Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355
“Siemens RT Image Suite Software VA30_SP02 Recall: Incorrect Dose Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64450-siemens-rt-image-suite-software-va30-sp02-recall-incorrect-dose. Based on FDA recall #Z-3005-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3005-2020%22&limit=1).
The FDA announced on Aug. 19, 2020, that Siemens Medical Solutions USA, Inc. is recalling Syngo.via RT Image Suite software due to a calibration offset hazard. This defect can potentially result in an incorrect dose or dose applied to the wrong location during treatment planning.
How to tell if you have it
Brand: Siemens
Product: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK
Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
According to the FDA, a calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm. If this misadjustment is not recognized during treatment planning or remains undetected during position verification, it can potentially result in an incorrect dose or dose applied to the wrong location.
Context
GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Other recent recalls of similar products include Siemens ARTIS icono Ceiling Monitor Recall (June 8, 2026), Siemens ARTIS Icono Biplane Recall (May 20, 2026), and Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026). Other recent recalls of similar products include RayStation/RayPlan Software Recall (Nov. 28, 2025), RayStation/RayPlan Software 11A Recalls (Nov. 28, 2025), and RayStation 2024B Software Recall (Nov. 28, 2025).
How to tell if you have this one
Check if your Siemens radiation treatment system has software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK. Affected units include specific serial numbers listed in the recall notice.
Brand
Siemens
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your radiation treatment system's software version and license code against the list of affected serial numbers provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
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 2.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-3005-2020 (August 19, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3005-2020 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.