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 May 13, 2015 to Dec 30, 2015.

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 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,…

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 d…

FDA Devices Moderate Nov 4, 2015

ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packa…

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…

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 s…

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 rev…

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 th…

FDA Devices Moderate Sep 30, 2015

ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Prod…

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 in…

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) intend…

FDA Devices Moderate Aug 26, 2015

Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, …

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 …

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 syst…

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 fo…

FDA Devices Moderate Aug 12, 2015

Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including…

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 …

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 n…

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, S300…

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 2…

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…

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 ult…

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…

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,…

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 …

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 applic…

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 dia…

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 adm…

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 o…

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 trans…

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…

FDA Devices Moderate Jun 3, 2015

SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray tran…

FDA Devices Moderate Jun 3, 2015

SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray tra…

FDA Devices Moderate Jun 3, 2015

SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can…

FDA Devices Moderate Jun 3, 2015

SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, end…

FDA Devices Moderate May 13, 2015

AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray…

FDA Devices Moderate May 13, 2015

ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Siemens Medical Solutions USA, Inc with Zimmer Biomet, Inc. →

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.