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 Jan 14, 2015 to Nov 11, 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.
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,…
ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to d…
SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the…
SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the s…
ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Prod…
ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is in…
Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intend…
Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, …
Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed …
Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera syst…
Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including…
Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301
Artis Q systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not …
Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290
Biograph mCT S(64)-4R, Model Number 10248672
Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302
Biograph mCT S(40)-4R, Model Number 10248671
SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743
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…
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000…
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ult…
SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane…
SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report,…
SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane …
syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient adm…
SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures o…
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…
SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat…
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…
SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray tra…
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…
ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for…
Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and arch…
MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produc…
Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all availa…
E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or organ, using the following techniq…
ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to d…
Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniqu…
SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: The intended …
Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obes…
ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - …
ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is intended for the following ap…
Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photo…
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in h…
Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies.
SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmiss…
Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is dedicated angiography systems developed for single a…
Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and bi…
e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the following tec…
Nearby Manufacturers
Other firms with recall activity tracked in the PlainRecalls index.
Data Sources
Explore Related Data
Read our methodology — how this data is sourced, computed, and verified.