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 Jun 29, 2016 to Mar 22, 2017.

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 Mar 22, 2017

Artis Q and Q.Zen fluoroscopic x-ray system

FDA Devices Moderate Mar 22, 2017

Artis Zee and Zeego fluoroscopic x-ray system

FDA Devices Moderate Mar 15, 2017

PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerato…

FDA Devices Moderate Mar 15, 2017

Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care …

FDA Devices Moderate Mar 15, 2017

MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to del…

FDA Devices Moderate Mar 15, 2017

MEVATRON M 6730/6740 (MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to de…

FDA Devices Moderate Mar 15, 2017

MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelera…

FDA Devices Moderate Mar 15, 2017

Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care profes…

FDA Devices Moderate Mar 15, 2017

Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health…

FDA Devices Moderate Feb 22, 2017

ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of lin…

FDA Devices Moderate Feb 22, 2017

ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of lin…

FDA Devices Moderate Feb 22, 2017

PRIMUS Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelera…

FDA Devices Moderate Feb 22, 2017

ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy system Product Usage: The intended use o…

FDA Devices Moderate Feb 8, 2017

Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exa…

FDA Devices Moderate Feb 8, 2017

Syngo.plaza, picture archiving and communications system.

FDA Devices Moderate Jan 18, 2017

Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomograph…

FDA Devices Moderate Jan 18, 2017

Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomogra…

FDA Devices Moderate Jan 18, 2017

Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) …

FDA Devices Moderate Jan 18, 2017

Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) …

FDA Devices Moderate Jan 18, 2017

Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) …

FDA Devices Moderate Jan 18, 2017

Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and …

FDA Devices Moderate Jan 18, 2017

BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) …

FDA Devices Moderate Jan 18, 2017

Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT…

FDA Devices Moderate Jan 18, 2017

Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) …

FDA Devices Moderate Jan 4, 2017

SOMATOM Perspective, Computed tomography x-ray system

FDA Devices Moderate Dec 21, 2016

SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-r…

FDA Devices Moderate Dec 14, 2016

SOMATOM Force, System x-ray, tomography, computed

FDA Devices Moderate Dec 7, 2016

Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. Radiology: The ACUSON SC2000 ultrasound imaging s…

FDA Devices Moderate Nov 23, 2016

SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cros…

FDA Devices Moderate Nov 23, 2016

SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross…

FDA Devices Moderate Nov 23, 2016

SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition AS systems are intended to produce cross-sectional images …

FDA Devices Moderate Nov 23, 2016

SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are intended to produce cross-sectional images …

FDA Devices Moderate Nov 23, 2016

Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplan…

FDA Devices Moderate Nov 16, 2016

SOMATOM Definition AS system, x-ray, tomography, computed

FDA Devices Moderate Oct 19, 2016

Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: plana…

FDA Devices Moderate Oct 12, 2016

Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical pr…

FDA Devices Moderate Oct 5, 2016

Syngo.plaza, Picture Archiving and Communication System

FDA Devices Moderate Oct 5, 2016

Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, process…

FDA Devices Moderate Oct 5, 2016

PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of ca…

FDA Devices Moderate Oct 5, 2016

ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray pho…

FDA Devices Moderate Sep 28, 2016

Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, an…

FDA Devices Moderate Sep 21, 2016

Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital me…

FDA Devices Moderate Sep 14, 2016

e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the body or organ, using the fol…

FDA Devices Moderate Aug 31, 2016

SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system

FDA Devices Moderate Aug 17, 2016

ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22 AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are …

FDA Devices Moderate Aug 17, 2016

ARTIS ZEE AND ZEEGO, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems dev…

FDA Devices Moderate Aug 17, 2016

AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angi…

FDA Devices Moderate Aug 17, 2016

Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281,…

FDA Devices Moderate Jul 6, 2016

Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,

FDA Devices Moderate Jun 29, 2016

BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron …

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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