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.

476–500 of 796

  • HighFDA (Devices)·Z-0972-2017·2017-01-18

    Siemens Recalls Artis Q Angiographic X-Ray Systems for Generator Defects

    Siemens is recalling Artis Q angiographic x-ray systems due to potential high-voltage generator failures and rare image display loss.

    Product
    Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1000-2017·2017-01-18

    Siemens Biograph mCT 20 Excel PET/CT Scanner Recall for Laser Cover Windows

    Siemens is recalling 51 Biograph mCT 20 Excel scanners because laser cover windows may fall off.

    Product
    BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0994-2017·2017-01-18

    Siemens Biograph mCT X-4R Laser Cover Window Recall

    Siemens is recalling 71 Biograph mCT X-4R scanners because laser cover windows may fall off.

    Product
    Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic inform
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1001-2017·2017-01-18

    Siemens Biograph mCT Flow Edge-4R Scanner Recall for Laser Cover Windows

    Siemens Medical Solutions is recalling one Biograph mCT Flow Edge-4R scanner because laser cover windows may fall off.

    Product
    Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0992-2017·2017-01-18

    Siemens Biograph mCT PET/CT Scanner Laser Cover Window Recall

    Siemens is recalling 41 Biograph mCT PET/CT scanners because laser cover windows may fall off.

    Product
    Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0997-2017·2017-01-18

    Siemens Biograph mCT X-3R Scanners Recalled for Falling Laser Cover Windows

    Siemens Medical Solutions is recalling 18 Biograph mCT X-3R scanners because laser cover windows may fall off.

    Product
    Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic inform
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0995-2017·2017-01-18

    Siemens Biograph mCT Scanners Recalled for Falling Laser Cover Windows

    Siemens Medical Solutions is recalling 88 Biograph mCT scanners because laser cover windows may fall off.

    Product
    Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0998-2017·2017-01-18

    Siemens Biograph mCT PET/CT Scanner Laser Cover Window Recall

    Siemens Medical Solutions is recalling Biograph mCT PET/CT scanners because laser cover windows may fall off.

    Product
    Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0996-2017·2017-01-18

    Siemens Biograph mCT PET/CT Scanners Recalled for Falling Laser Cover Windows

    Siemens Medical Solutions is recalling 102 Biograph mCT PET/CT scanners because laser cover windows may fall off.

    Product
    Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0999-2017·2017-01-18

    Siemens Biograph mCT-X Scanner Recall Due to Falling Laser Cover Windows

    Siemens Medical Solutions is recalling Biograph mCT-X scanners because laser cover windows may fall off.

    Product
    Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0971-2017·2017-01-18

    Siemens Artis zee/zeego Angiographic X-ray System Recall for Generator Defects

    Siemens is recalling Artis zee/zeego angiographic x-ray systems due to potential high-voltage generator failures and rare image display loss.

    Product
    Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1002-2017·2017-01-18

    Siemens Biograph mCT Flow 40-4R Laser Cover Window Recall

    Siemens Medical Solutions is recalling Biograph mCT Flow 40-4R scanners because laser cover windows may fall off.

    Product
    Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0993-2017·2017-01-18

    Siemens Biograph mCT Scanners Recalled for Falling Laser Cover Windows

    Siemens is recalling 34 Biograph mCT scanners because laser cover windows may fall off, posing a potential hazard to users.

    Product
    Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0919-2017·2017-01-04

    Siemens Recalls SOMATOM Scope CT Systems for Power Cutout Risk

    Siemens is recalling 13 SOMATOM Scope CT systems to replace a component that could cause a power cutout during use.

    Product
    SOMATOM Scope, Computed tomography x-ray system
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0921-2017·2017-01-04

    Siemens Recalls CT Systems for Potential Power Cutout Defect

    Siemens is recalling 13 SOMATOM Perspective CT systems to replace a component that could cause power cutouts during use.

    Product
    SOMATOM Perspective, Computed tomography x-ray system
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0744-2017·2016-12-21

    Siemens SOMATOM Definition Edge CT Systems Recalled for Software Bug Fixes

    Siemens Medical Solutions is recalling 104 SOMATOM Definition Edge CT systems to install a software update that fixes bugs and improves performance.

    Product
    SOMATOM Definition Edge System, x-ray, tomography, computed 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0742-2017·2016-12-21

    Siemens SOMATOM Definition AS CT Systems Recalled for Software Bug Fixes

    Siemens Medical Solutions USA is recalling 104 SOMATOM Definition AS CT systems to install software and firmware updates that fix bugs and improve performance.

    Product
    SOMATOM Definition AS System, x-ray, tomography, computed 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0743-2017·2016-12-21

    Siemens SOMATOM Definition Flash CT Systems Recalled for Software Update

    Siemens is recalling 104 SOMATOM Definition Flash CT systems to install a software and firmware update that fixes bugs and improves performance.

    Product
    SOMATOM Definition Flash System, x-ray, tomography, computed 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0692-2017·2016-12-14

    Siemens Recalls SOMATOM Force CT Systems for Software Bugs

    Siemens is recalling 48 SOMATOM Force CT systems to install a software update that fixes bugs causing image errors and scan aborts.

    Product
    SOMATOM Force, System x-ray, tomography, computed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0667-2017·2016-12-07

    Siemens Recalls Z6Ms Transesophageal Transducers Due to Material Deterioration

    Siemens is recalling 33 Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems because the material covering the articulating section has deteriorated, causing acquisition errors.

    Product
    Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. Radiology: The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0608-2017·2016-11-23

    Siemens Recalls CT Systems for Software Safety Bug Fixes

    Siemens is recalling seven CT systems to install a software update that fixes bugs and corrects potential safety issues.

    Product
    SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are 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 diff
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0603-2017·2016-11-23

    Siemens AXIOM Artis Angiographic X-ray Systems Recalled for Footswitch Defect

    Siemens is recalling AXIOM Artis angiographic x-ray systems because the semi-automatic focus switch may fail when the footswitch is pressed multiple times.

    Product
    AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures tha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0602-2017·2016-11-23

    Siemens Artis zee/zeego Angiographic X-ray Systems Recalled for Footswitch Defect

    Siemens is recalling Artis zee/zeego angiographic x-ray systems because the semi-automatic focus switch may fail when the footswitch is pressed multiple times.

    Product
    Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0604-2017·2016-11-23

    Siemens SOMATOM CT Systems Recalled for Loose Light Marker Windows

    Siemens is recalling 762 SOMATOM CT systems because loose light marker windows could allow access to rotating or electrical parts.

    Product
    SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are 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 spi
    Category
    Medical Device
    Distribution
    Distributed nationwide