The Recall Desk

Manufacturer

Siemens Medical Solutions USA, Inc.

796 recalls in our database name Siemens Medical Solutions USA, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
796
Critical
16
Severe
69
Most recent
2026-07-08

Of the 796 recalls from Siemens Medical Solutions USA, Inc. we have scored against our rubric, 16 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 69 (9%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

651–675 of 796

  • ModerateFDA (Devices)·Z-1645-2015·2015-06-03

    Siemens SOMATOM Emotion 16 CT Scanner Software Recall

    Siemens is recalling 75 SOMATOM Emotion 16 CT scanners due to software bugs that may cause system crashes, image freezes, or database locks, potentially requiring patients to be rescanned.

    Product
    SOMATOM Emotion 16, 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1667-2015·2015-06-03

    Siemens Ysio Max Radiographic System Recalled for Software Data Loss

    Siemens is recalling 133 Ysio Max radiographic systems because a software defect can delete acquired images and studies, requiring patients to repeat exposures.

    Product
    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 c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1646-2015·2015-06-03

    Siemens SOMATOM Perspective CT Scanner Software Recall

    Siemens is recalling 75 SOMATOM Perspective CT scanners due to software bugs that may cause system crashes, image freezes, or database locks, potentially requiring patients to be rescanned.

    Product
    SOMATOM Perspective; 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1669-2015·2015-06-03

    Siemens Luminos Agile Max Imaging System Software Recall

    Siemens is recalling 133 Luminos Agile Max imaging systems due to a software defect that causes image loss and connection issues.

    Product
    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 a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1583-2015·2015-05-13

    Siemens Axiom Aristos FX Radiography System Cable Cart Recall

    Siemens is recalling 43 Axiom Aristos FX radiography systems because a cable cart defect could cause the cable holder to drop and hit patients or operators.

    Product
    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 exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1581-2015·2015-05-13

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Image Capture Failures

    Siemens is recalling 186 ACUSON SC2000 ultrasound systems because they may fail to capture images or clips during routine scans.

    Product
    ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1584-2015·2015-05-13

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Image Loss

    Siemens Medical Solutions USA is recalling 476 ACUSON SC2000 ultrasound systems because post-exercise images may be lost during Stress Echo procedures.

    Product
    ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. 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, A
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1445-2015·2015-04-22

    Siemens Artis Q and Q zen Angiography Systems Recalled for Electrical Connection

    Siemens is recalling 139 Artis Q and Q zen angiography systems nationwide because an electrical connection in the equipment cabinet may not be installed correctly.

    Product
    Artis Q/ Q zen systems; Artis Q/ Q zen 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 angiog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1354-2015·2015-04-08

    Siemens Syngo.plaza PACS Recalled for Incomplete Archived Studies

    Siemens Medical Solutions is recalling four Syngo.plaza PACS units because they may leave partially archived studies unarchived during pre-fetch operations.

    Product
    Syngo.plaza. 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.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1308-2015·2015-04-01

    Siemens MAGNETOM MRI Systems Recalled for Gradient Output Supervision Defect

    Siemens Medical Solutions is recalling 132 MAGNETOM MRI systems because a defect in gradient output supervision could allow outputs to exceed safety limits, potentially causing peripheral nerve stimulation.

    Product
    MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the inter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1282-2015·2015-03-25

    Siemens LANTIS Oncology Servers Recalled for Potential Treatment Errors

    Siemens is recalling 87 LANTIS Oncology Information System servers because using unvalidated operating systems may lead to incorrect patient treatment.

    Product
    Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0984-2015·2015-03-25

    Siemens ARTISTE MV System Linear Accelerator Recalled for Software Issue

    Siemens is recalling three ARTISTE MV System linear accelerators due to a software issue that may cause a dark current phenomenon during specific cancer treatments.

    Product
    ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1296-2015·2015-03-25

    Siemens Symbia E SPECT Systems Recalled for Incorrect Radial Motor Assembly

    Siemens Medical Solutions is recalling 419 Symbia E SPECT systems worldwide because radial motor drives were incorrectly assembled backwards during a customer service action.

    Product
    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 techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1297-2015·2015-03-25

    Siemens E.CAM Systems Recalled for Incorrectly Assembled Radial Motor Drives

    Siemens Medical Solutions is recalling E.CAM emission computed tomography systems because radial motor drives replaced during service were assembled backwards.

    Product
    E.CAM emission computed tomography 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 588 keV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1267-2015·2015-03-18

    Siemens CT System Recalled for Image Artifacts and Safety Issues

    Siemens Medical Solutions is recalling 12 SOMATOM Force CT systems due to potential image artifacts and safety-related software issues.

    Product
    SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: The intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1119-2015·2015-02-25

    Siemens Artis One Angiography System Recalled for Monitor Failure

    Siemens Medical Solutions is recalling one Artis One angiography system because the monitor may fail and require a power cycle to resume operation.

    Product
    Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1063-2015·2015-02-18

    Siemens ACUSON S2000 Breast Scanner Recall for Detachment Risk

    Siemens is recalling 24 ACUSON S2000 breast scanners because the scanner arm may detach from the column.

    Product
    ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1086-2015·2015-02-18

    Siemens Symbia S Series Medical Imaging Systems Recalled for Bearing Failure

    Siemens Medical Solutions is recalling 719 Symbia S series systems because a linear bearing car may fail, allowing ball bearings to fall out.

    Product
    The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in ra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1087-2015·2015-02-18

    Siemens Symbia T Series Medical Imaging Systems Recalled for Bearing Failure

    Siemens Medical Solutions is recalling Symbia T series imaging systems because a linear bearing car may fail, allowing ball bearings to fall out.

    Product
    The Siemens Symbia T series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in ra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1059-2015·2015-02-11

    Siemens LINAC Accelerators Recalled for Overheating and Smoke Emission

    Siemens Medical Solutions is recalling 310 LINAC Accelerators because the internal electric board may overheat, causing thermal damage and smoke emission.

    Product
    LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON KDS-2, MEVATRON KD-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1056-2015·2015-02-11

    Siemens ACUSON SC2000 Ultrasound System Control Panel Bolt Recall

    Siemens is recalling 230 ACUSON SC2000 ultrasound systems because a bolt holding the control panel may fail, preventing the panel from locking into position.

    Product
    ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdomin
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1013-2015·2015-02-04

    Siemens Syngo RT Therapist Software Recall Due to Mistreatment Risk

    Siemens is recalling Syngo RT Therapist software because a combination with CTVision may cause wrong offset calculations, leading to patient mistreatment.

    Product
    Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1027-2015·2015-02-04

    Siemens Syngo.plaza PACS Recalled for Potential Image Loss During System Crashes

    Siemens Medical Solutions is recalling 50 Syngo.plaza PACS systems because images may be lost if the system crashes before saving data to the hard disk.

    Product
    Syngo.plaza: 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 suppor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2015·2015-01-28

    Siemens Radiographic Systems Recalled for Potential Image Flipping Errors

    Siemens is recalling 11 Ysio Max, Luminos dRF Max, and Agile Max systems because software errors may cause images to flip, leading to incorrect labels and potential misdiagnosis.

    Product
    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 hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skul
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0980-2015·2015-01-21

    Siemens Linear Accelerators Recalled for Unauthorized Component Safety Risks

    Siemens Medical Solutions is recalling 320 linear accelerators because unauthorized third-party components may cause patient or operator injury and dose calculation errors.

    Product
    Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON
    Category
    Medical Device
    Distribution
    Distributed nationwide