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Siemens Medical Solutions USA, Inc

796 recalls on record · Latest: Jul 8, 2026

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Agency notice ledger

Federal filing book Siemens Medical Solutions U… HEAVY-BOOK · SINGLE-AGENCY

#3 of 14,151 · 796 notices · 0.762% archive

  • BOOK 796 notices
  • RANK #3 of 14,151
  • SHARE 0.762% archive
  • AGENCY FDA Devices (796)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jul 8, 2026
  • PHOTO Ford

Nearest notice-volume peer: Ford (14 notice gap)

Siemens Medical Solutions USA, Inc sits #3 of 14,151 (3rd among 14,151 firms) with 796 federal notices — about 0.762% of the archive (heavy-book tercile). Rank counts issuance frequency, not danger. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Siemens Medical Solutions U…'s standing among 14,151 recalling firms

Siemens Medical Solutions USA, Inc ranks 3rd of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Siemens Medical Solutions U… vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

796 3rd of 14151 higher than 14,148 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-14

Siemens Medical Solutions U… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Siemens Medical Solutions USA, Inc carries 796 distinct federal notices, ranked #3 of 14,151 (heavy-book).

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Mar 2, 2016

software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images.

FDA Devices Moderate Mar 2, 2016

Mammomat Inspiration with Tomosynthesis functionality

FDA Devices Moderate Jan 27, 2016

The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.

FDA Devices Moderate Jan 13, 2016

Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.

FDA Devices Moderate Dec 30, 2015

Syngo Imaging XS is a Picture Archiving and Communication System (PACS)

FDA Devices Moderate Dec 30, 2015

Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.

FDA Devices Moderate Dec 30, 2015

MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).

FDA Devices Moderate Dec 2, 2015

Syngo Imaging VB36D_HF02. Radiological image processing system.

FDA Devices Moderate Nov 18, 2015

MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.

FDA Devices Moderate Nov 11, 2015

e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.

FDA Devices Moderate Nov 4, 2015

ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to deliver x-ray radiation for therapeutic treatment of cancer.

FDA Devices Moderate Nov 4, 2015

ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.

FDA Devices Moderate Nov 4, 2015

CIOS ALPHA; image intensified fluoroscopic x-ray system

FDA Devices Moderate Oct 14, 2015

SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.

FDA Devices Moderate Oct 14, 2015

SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.

FDA Devices Moderate Oct 14, 2015

SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.

FDA Devices Moderate Oct 14, 2015

Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.

FDA Devices Moderate Oct 14, 2015

SOMATOM Definition Flash; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.

FDA Devices Moderate Sep 30, 2015

ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software applica

FDA Devices Moderate Sep 23, 2015

ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structur

FDA Devices Moderate Sep 9, 2015

Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enab

FDA Devices Moderate Aug 26, 2015

Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

FDA Devices Moderate Aug 26, 2015

Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging facility or in a mobile/ transportable imaging environment.

FDA Devices Moderate Aug 26, 2015

Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.

FDA Devices Moderate Aug 26, 2015

Siemens Symbia T Series, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.

FDA Devices Moderate Aug 12, 2015

Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

FDA Devices Moderate Aug 12, 2015

Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301

FDA Devices Moderate Aug 12, 2015

Artis Q systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

FDA Devices Moderate Aug 12, 2015

Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290

FDA Devices Moderate Aug 12, 2015

Biograph mCT S(64)-4R, Model Number 10248672

FDA Devices Moderate Aug 12, 2015

Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302

FDA Devices Moderate Aug 12, 2015

Biograph mCT S(40)-4R, Model Number 10248671

FDA Devices Moderate Aug 12, 2015

SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743

FDA Devices Moderate Aug 12, 2015

Axiom Artis systems, dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

FDA Devices Moderate Aug 12, 2015

Biograph mCT Flow Edge-4R, Model Number 10528955

FDA Devices Moderate Aug 12, 2015

ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines 6C1HD - model numbers: 10442008 6C1HD Needle Guide, S3000; 10440586 6C1 HD Biopsy Guide, S2000 18L6 - model numbers: 10442007 18L6 Biopsy Guide, S3000 10044200 S2000 Biopsy Starter Kit, 18L6 HD 10855189 18L6 HD Biopsy Starter Kit, S1000 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/

FDA Devices Moderate Aug 12, 2015

Biograph mCT X-4R, Model Number 10248670

FDA Devices Moderate Aug 5, 2015

ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vas

FDA Devices Moderate Aug 5, 2015

ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

FDA Devices Moderate Jul 8, 2015

ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to

FDA Devices Moderate Jul 8, 2015

SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.

FDA Devices Moderate Jul 8, 2015

SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.

FDA Devices Moderate Jul 8, 2015

SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.

FDA Devices Moderate Jul 8, 2015

Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients

FDA Devices Moderate Jul 1, 2015

Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. .

FDA Devices Moderate Jun 10, 2015

syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration. The system electronically displays stores, retrieves, transfers, exchanges, and prints.

FDA Devices Moderate Jun 10, 2015

Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

FDA Devices Moderate Jun 3, 2015

SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position.

FDA Devices Moderate Jun 3, 2015

SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.

FDA Devices Moderate Jun 3, 2015

SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency treatment on an outpatient basis, as well as for bedside examinations.

Siemens Medical Solutions U… sits in the heavy federal notice book

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (796 here — heavy-book).

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Frequently Asked Questions

How many federal recall notices name Siemens Medical Solutions U…?
PlainRecalls indexes 796 distinct federal recall events naming Siemens Medical Solutions USA, Inc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Siemens Medical Solutions U… sit among other recalling firms?
Siemens Medical Solutions USA, Inc ranks #3 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Siemens Medical Solutions U…'s notices?
FDA Devices accounts for 796 of this firm's 796 indexed notices.
What product category dominates Siemens Medical Solutions U…'s filing book?
Filings for Siemens Medical Solutions USA, Inc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous?
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Siemens Medical Solutions USA, Inc: 796 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Siemens Medical Solutions USA, Inc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026