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.

751–775 of 796

  • SevereFDA (Devices)·Z-0052-2014·2013-10-30

    Siemens Acuson SC2000 Ultrasound Systems Recalled for Inaccurate 3D Images

    Siemens is recalling 26 Acuson SC2000 ultrasound systems because a software issue causes inaccurate 3D images, which may lead to ablation in the wrong location.

    Product
    Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2095-2013·2013-09-04

    Siemens Recalls Linear Accelerator Tabletops Due to Screw Breakage Risk

    Siemens is recalling specific linear accelerator tabletops because manufacturing errors may cause screws to break off, potentially affecting patient safety.

    Product
    PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083. Product Usage: The intended use of the SIEMENS branded, ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray ph
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2108-2013·2013-09-04

    Siemens Axiom Artis C-arm Systems Recalled for Incorrect Channel Nuts

    Siemens Medical Solutions USA is recalling 178 Axiom Artis C-arm angiographic x-ray systems because third-party installers may have used incorrect channel nuts.

    Product
    Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1945-2013·2013-08-21

    Siemens AXIOM Artis zeego x-ray system safety notice issued

    Siemens issued a customer safety notice regarding system information overlays after brake functional checks on the AXIOM Artis zeego x-ray system.

    Product
    Siemens AXIOM Artis zeego x-ray, angiographic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1975-2013·2013-08-21

    Siemens syngo.plaza Mammography Software Recall for Image Alignment Issues

    Siemens is recalling syngo.plaza software due to potential issues with mammography image laterality and alignment.

    Product
    Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1848-2013·2013-08-07

    Siemens Luminos dRF Fluoroscopic X-Ray System Recalled for Software Error

    Siemens is recalling four Luminos dRF Fluoroscopic X-Ray systems due to a software error that may cause the table to tilt and collide with the floor.

    Product
    Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1859-2013·2013-08-07

    Siemens syngo Dynamics Information System Recall for Data Loss Risk

    Siemens is recalling syngo Dynamics Information System versions 9.5 and VA10A because images may not be saved when specific modality settings are used.

    Product
    syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo¿ Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. syngo¿ Dynamics is not
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1795-2013·2013-07-31

    Siemens Axiom Aristos MX Flat Panel Imager Recalled for Finger Injury Risk

    Siemens is recalling 401 Axiom Aristos MX digital imagers because the table top float function can trap and crush fingers.

    Product
    Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1782-2013·2013-07-31

    Siemens ARTIS zee and zeego X-ray Systems Recalled for Software Issue

    Siemens is recalling 29 ARTIS zee and zeego x-ray systems due to a software issue affecting rotational 3D-acquisition programs with real-time subtraction.

    Product
    ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1750-2013·2013-07-24

    Siemens AXIOM Artis zee/zeego Systems Recalled for Generator Power Supply Defect

    Siemens is recalling 23 AXIOM Artis zee/zeego angiographic x-ray systems because a tolerance problem in the generator power supply may cause the generator to fail.

    Product
    Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1694-2013·2013-07-17

    Siemens Mammomat Inspiration Mammography Systems Recalled for Potential Malfunction

    Siemens is recalling three Mammomat Inspiration mammography systems due to a potential malfunction that could cause patient bruising during specific imaging procedures.

    Product
    Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1663-2013·2013-07-10

    Siemens Linear Accelerator Recall Due to Potential Patient Mistreatment

    Siemens is recalling specific linear accelerator systems because a difficult-to-interpret calibration issue may have resulted in the mistreatment of cancer patients.

    Product
    Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability. The intended use of the SIEMENS branded MEVATRON", ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1562-2013·2013-06-26

    Siemens ARTISTE Linear Accelerator Recall for Image Quality Degradation

    Siemens is recalling 8 ARTISTE linear accelerators due to potential image quality degradation that may affect patient position verification during cancer treatment.

    Product
    ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1182-2013·2013-05-08

    Siemens Medical Solutions Recalls RT Therapist Software for Safety Issues

    Siemens Medical Solutions is recalling RT Therapist software versions 4.2.108 to fix multiple safety-related issues on linear accelerator systems.

    Product
    Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1105-2013·2013-04-24

    Siemens syngo WorkFlow SLR Recall for Patient Data Display Error

    Siemens Medical Solutions is recalling syngo WorkFlow SLR software due to a defect that may display the wrong patient's documents in signed reports.

    Product
    Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and syste
    Category
    Medical Device
    Distribution
    31 states
  • SevereFDA (Devices)·Z-1081-2013·2013-04-17

    Siemens ACUSON SC2000 Ultrasound System Recalled for Temperature Display Error

    Siemens is recalling ACUSON SC2000 ultrasound systems with specific hardware due to a temperature display error that may underestimate transducer heat, posing a burn risk.

    Product
    Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult C
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1097-2013·2013-04-17

    Siemens Recalls Angiographic X-Ray Systems Due to Table Collision Risk

    Siemens is recalling 51 angiographic x-ray systems because a malfunction in the table vertical lift could cause a collision if obstructed by a solid object.

    Product
    Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. Angiographic x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1077-2013·2013-04-17

    Siemens Medical Solutions Recalls Elekta MOSAIQ Software Due to Safety Risk

    Siemens Medical Solutions is recalling Elekta MOSAIQ Oncology Information System software versions below 2.41 due to a potential safety risk identified by the manufacturer.

    Product
    ELEKTA MOSAIQ SW version below 2.41 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.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1036-2013·2013-04-10

    Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions for Primus and Oncor linear accelerators to address performance defects and safety issues.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1043-2013·2013-04-10

    Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions for linear accelerators to address multiple performance defects and safety issues.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.1, Part No. 8147675, Current R640; Product Usage: The intended us
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1042-2013·2013-04-10

    Siemens COHERENCE RT Therapist Software Recall for Performance Defects

    Siemens is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues identified during final system testing.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i, Part No. 7341428, Current R610/R630; Product Usage: The intended us
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1044-2013·2013-04-10

    Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Performance Defects

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and safety issues that were not considered critical for immediate correction.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.0, Part No. 8139847, Current R630; Product Usage: The intended us
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1041-2013·2013-04-10

    Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues identified during final system testing.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.2, Part No. 10568431, Current R640; Product Usage: The intended use
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1040-2013·2013-04-10

    Siemens COHERENCE RT Therapist Software Recall for Performance Defects

    Siemens is recalling COHERENCE RT Therapist software versions to address performance defects and safety issues identified during final system testing.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.1, Part No. 8147667, Current R640; Product Usage: The intended use
    Category
    Medical Device
    Distribution
    0 states