PlainRecalls

Siemens Medical Solutions USA, Inc

525 recalls on record · Latest: Feb 11, 2026

Siemens Medical Solutions USA, Inc Recall Insight

Siemens Medical Solutions USA, Inc appears on 525 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.625% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 11, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Nov 27, 2019 to Dec 1, 2021.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Dec 1, 2021

Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Mo…

FDA Devices Moderate Dec 1, 2021

Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number…

FDA Devices Moderate Dec 1, 2021

Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure …

FDA Devices Moderate Dec 1, 2021

SOMATOM Definition AS with software syngo.CT VB20 Model #8098027

FDA Devices Moderate Dec 1, 2021

Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model …

FDA Devices Moderate Dec 1, 2021

Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Mo…

FDA Devices Moderate Dec 1, 2021

SOMATOM Force with software syngo.CT VB20 Model #10742326

FDA Devices Moderate Sep 29, 2021

Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMAT…

FDA Devices Moderate Sep 22, 2021

syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM…

FDA Devices Moderate Sep 8, 2021

Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 …

FDA Devices Moderate Jul 14, 2021

ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000

FDA Devices Moderate May 5, 2021

Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, bu…

FDA Devices Moderate May 5, 2021

Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of d…

FDA Devices Moderate May 5, 2021

Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137

FDA Devices Moderate Apr 14, 2021

Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abd…

FDA Devices Moderate Apr 7, 2021

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnost…

FDA Devices Moderate Mar 31, 2021

Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including…

FDA Devices Moderate Mar 10, 2021

Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynami…

FDA Devices Moderate Mar 3, 2021

ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and b…

FDA Devices Moderate Jan 20, 2021

SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus

FDA Devices Moderate Jan 20, 2021

Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno

FDA Devices Moderate Jan 20, 2021

Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functiona…

FDA Devices Moderate Jan 20, 2021

Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (funct…

FDA Devices Moderate Nov 11, 2020

ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for …

FDA Devices Moderate Oct 14, 2020

ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F

FDA Devices Moderate Sep 9, 2020

Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionuclides in the …

FDA Devices Moderate Sep 9, 2020

Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheteriza…

FDA Devices Moderate Sep 2, 2020

Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of…

FDA Devices Moderate Sep 2, 2020

E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or organ, usin…

FDA Devices Moderate Sep 2, 2020

Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobil…

FDA Devices Moderate Sep 2, 2020

Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging o…

FDA Devices Moderate Aug 12, 2020

SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-…

FDA Devices Moderate Aug 12, 2020

SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomi…

FDA Devices Moderate Aug 12, 2020

SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize anatomical structures by converting an X-…

FDA Devices Moderate Jun 24, 2020

MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual ener…

FDA Devices Moderate Jun 17, 2020

Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q…

FDA Devices Moderate Jun 10, 2020

ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Num…

FDA Devices Moderate Jun 3, 2020

Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194

FDA Devices Moderate May 20, 2020

Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray i…

FDA Devices Moderate May 20, 2020

Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray im…

FDA Devices Moderate May 13, 2020

System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without …

FDA Devices Moderate Apr 15, 2020

MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #094015…

FDA Devices Moderate Apr 15, 2020

ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control …

FDA Devices Moderate Mar 25, 2020

Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a fa…

FDA Devices Moderate Mar 25, 2020

Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Pro…

FDA Devices Moderate Mar 25, 2020

Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.

FDA Devices Moderate Feb 26, 2020

Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enabl…

FDA Devices Moderate Jan 22, 2020

Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnosti…

FDA Devices Moderate Dec 25, 2019

Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C

FDA Devices Moderate Nov 27, 2019

SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds