PlainRecalls

Siemens Medical Solutions USA, Inc

Compiled from official public sources by the editorial team.

790 recalls on record · Latest: Apr 22, 2026

Siemens Medical Solutions USA, Inc Recall Insight

Siemens Medical Solutions USA, Inc appears on 790 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.777% 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 Apr 22, 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 Aug 28, 2019 to Aug 12, 2020.

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 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 Aug 12, 2020

SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray…

FDA Devices Moderate Jul 29, 2020

syngo.via RT Image Suite with software versions syngo.via VB30 or VB40

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 Jun 3, 2020

Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mobile X-…

FDA Devices Moderate Jun 3, 2020

ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: is a family of dedicated angiography systems developed for s…

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 20, 2020

Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The Cios Alpha and Cios Spin are a mobile X-Ray system designed to …

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 May 13, 2020

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

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 Apr 15, 2020

ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

FDA Devices Moderate Apr 15, 2020

PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

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 Mar 25, 2020

Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959…

FDA Devices Moderate Mar 4, 2020

COHERENCE Oncologist, Model Nos. 07333680 & 07351898

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 Feb 26, 2020

Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-r…

FDA Devices Moderate Feb 26, 2020

Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-r…

FDA Devices Moderate Feb 26, 2020

ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of dedicated angiography systems…

FDA Devices Moderate Feb 26, 2020

Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray p…

FDA Devices Moderate Feb 26, 2020

Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray p…

FDA Devices Moderate Feb 26, 2020

Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an Xra…

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 Jan 15, 2020

Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical app…

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

FDA Devices Moderate Nov 20, 2019

Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model…

FDA Devices Moderate Oct 30, 2019

Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual en…

FDA Devices Moderate Sep 11, 2019

syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definit…

FDA Devices Moderate Sep 4, 2019

SOMATOM go.Top; Models #11061640 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of p…

FDA Devices Moderate Sep 4, 2019

SOMATOM go.Top; Models #11061648 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of p…

FDA Devices Moderate Sep 4, 2019

SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This computed tomography system is intended to generate and process cross-sectional …

FDA Devices Moderate Sep 4, 2019

SOMATOM go.All; Models #11061638 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of p…

FDA Devices Moderate Sep 4, 2019

SOMATOM go.Up; Models #11061620 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of pat…

FDA Devices Moderate Sep 4, 2019

SOMATOM go.Up; Models ##11061628 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of p…

FDA Devices Moderate Sep 4, 2019

SOMATOM go.All; Models #11061630 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of p…

FDA Devices Moderate Sep 4, 2019

Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number …

FDA Devices Moderate Aug 28, 2019

ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A…

FDA Devices Moderate Aug 28, 2019

MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643

FDA Devices Moderate Aug 28, 2019

ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, V…

FDA Devices Moderate Aug 28, 2019

MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582

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Data Sources

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.