Lower riskMedical device recall · FDA · Published November 19, 2021
Siemens SOMATOM Edge Plus CT Scanner Recall: Risk of Patient Misdiagnosis
Siemens recalls specific model SOMATOM Edge Plus CT scanners due to software version VB20_SP5 causing potential patient misdiagnosis. Affected units have serial numbers listed in the recall notice.
“Siemens SOMATOM Edge Plus CT Scanner Recall: Risk of Patient Misdiagnosis.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61513-siemens-somatom-edge-plus-ct-scanner-recall-risk-of-patient. Based on FDA recall #Z-0474-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0474-2022%22&limit=1).
The FDA announced on 2021-11-19 that Siemens Medical Solutions USA, Inc. is recalling SOMATOM Edge Plus Computed tomography systems due to software issues that may degrade head image quality and risk misdiagnosis. The recall affects 80 units distributed nationwide.
How to tell if you have it
Brand: Siemens
Product: SOMATOM Edge Plus-Computed tomography system Model 1026700
According to the FDA, software version VB20_SP5 may lead to a relevant degradation of head image quality. This issue presents a potential risk to patients of misdiagnosis.
Context
GovInfoNow's records show Siemens Medical Solutions USA, Inc. has had 182 other recalls on record since 2017-06-06. Other recent recalls include the Siemens ARTIS icono Ceiling Monitor Recall (2026-06-08), the Siemens ARTIS Icono Biplane Recall (2026-05-20), and the Siemens ARTIS Pheno VE30A/VE40A recall (2026-03-12). Other recent recalls of similar products include the Philips Brilliance CT 64 Medical Scanner Recall (2026-08-07), the Philips Ingenuity CT Scanners recall (2026-08-07), and the GE Healthcare Centricity Enterprise Archive V2/V3/V4 Software Recall (2026-07-31).
How to tell if you have this one
Check if your scanner has the model number 1026700 and serial numbers listed in the recall notice. The unique device identifier (UDI) is 04056869006949.
Brand
Siemens
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
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-0474-2022 (November 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0474-2022 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.