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.

226–250 of 796

  • HighFDA (Devices)·Z-1501-2020·2020-03-25

    Siemens Ysio X-Ray System Recalled for Unexpected Tube Stand Movement

    Siemens is recalling Ysio X-Ray systems because a software error may cause the ceiling tube stand to move unexpectedly when activated by the user.

    Product
    Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1495-2020·2020-03-25

    Siemens Artis Q Angiography Systems Recalled for Software Movement Issue

    Siemens is recalling Artis Q angiography systems because a software issue could block stand and table movements.

    Product
    Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and intervention
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1497-2020·2020-03-25

    Siemens Artis Angiography Systems Recalled for Software Movement Blockage

    Siemens is recalling Artis angiography systems because a software issue could block stand and table movements.

    Product
    Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1496-2020·2020-03-25

    Siemens Artis Q.zen Angiography Systems Recalled for Software Movement Issue

    Siemens is recalling Artis Q.zen angiography systems because a software issue could block stand and table movements.

    Product
    Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1346-2020·2020-03-04

    Siemens COHERENCE Oncologist Software Recall for Incorrect Dose Positioning

    Siemens is recalling COHERENCE Oncologist software due to a calculation error that could lead to incorrect patient repositioning and radiation dose delivery to the wrong location.

    Product
    COHERENCE Oncologist, Model Nos. 07333680 & 07351898
    Category
    Medical Device
    Distribution
    16 states
  • SevereFDA (Devices)·Z-1333-2020·2020-02-26

    Siemens Uroskop Omnia max Recalled for Collision Control Override Risk

    Siemens is recalling 192 Uroskop Omnia max devices because a bypass key can override collision controls, creating a risk of collision with obstacles or persons.

    Product
    Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system is designed primarily for urological diagnosis and the support of urological therapeutic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1331-2020·2020-02-26

    Siemens Luminos dRF Max Recalled for Collision Control Override Risk

    Siemens is recalling 46 Luminos dRF Max devices because an override function can disable collision controls, creating a risk of collision with obstacles or persons.

    Product
    Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1338-2020·2020-02-26

    Siemens Luminos Agile Max Recalled for Software Bug Affecting Patient Images

    Siemens is recalling 475 Luminos Agile Max devices due to a software bug that may assign one image to two patients, potentially affecting diagnosis.

    Product
    Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeleta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1332-2020·2020-02-26

    Siemens Luminos Agile Max X-ray System Recalled for Collision Risk

    Siemens is recalling 475 Luminos Agile Max X-ray systems because a bypass key can override collision controls, creating a risk of collision with obstacles or persons.

    Product
    Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeleta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2020·2020-02-26

    Siemens Ysio Max Radiographic System Recalled for Software Bug

    Siemens Medical Solutions is recalling 507 Ysio Max radiographic systems because a software bug may assign one image to two different patients, potentially affecting medical diagnosis.

    Product
    Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the whole body including: skull, chest, abdomen, and extremities and may be used on ped
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1337-2020·2020-02-26

    Siemens Luminos dRF Max Recalled for Software Bug Affecting Patient Images

    Siemens Medical Solutions USA, Inc. is recalling 46 Luminos dRF Max digital radiography systems due to a software bug that may assign one image to two different patients, potentially affecting medical diagnosis.

    Product
    Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1340-2020·2020-02-26

    Siemens ARTIS Pheno-Interventional Fluoroscopic X-Ray System Recalled for Robotic Stand Defect

    Siemens Medical Solutions is recalling 96 ARTIS Pheno-Interventional Fluoroscopic X-Ray Systems because safety brakes may block the robotic stand, preventing intended movements.

    Product
    ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0807-2020·2020-01-22

    Siemens ARTIS pheno X-Ray System Recalled for Potential Collision Sensor Blockage

    Siemens is recalling six ARTIS pheno X-ray systems because a collision sensor may falsely activate, permanently blocking system movement.

    Product
    Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0782-2020·2020-01-15

    Siemens Cios Alpha Mobile X-Ray System Recalled for C-Arm Holder Crack

    Siemens Medical Solutions is recalling Cios Alpha mobile X-ray systems because a crack in the C-arm holder could compromise stability and lead to injury.

    Product
    Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0695-2020·2019-12-25

    Siemens Artis zee X-Ray System Recalled for Collision Sensor Defect

    Siemens is recalling three Artis zee Interventional Fluoroscopic X-Ray Systems because a collision sensor defect may block tabletop movement, potentially delaying or interrupting procedures.

    Product
    Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0265-2020·2019-11-27

    Siemens SOMATOM go.Top CT Systems Recalled for Missing Dose Documentation

    Siemens is recalling 14 SOMATOM go.Top CT systems in seven states because they fail to document radiation dose or issue alerts during specific interventional procedures.

    Product
    SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0406-2020·2019-11-20

    Siemens SOMATOM CT Scanner Software Recall for System Crashes

    Siemens Medical Solutions is recalling syngo CT VB20 software for SOMATOM CT scanners due to scan aborts and system crashes.

    Product
    Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model #10431700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0160-2020·2019-10-30

    Siemens Mammomat Revelation Recall for Biopsy Software Error

    Siemens is recalling Mammomat Revelation mammography systems with specific software due to a rare error that can make the workstation unresponsive during biopsies.

    Product
    Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2440-2019·2019-09-11

    Siemens SOMATOM CT Software Recall for Workflow Interruptions

    Siemens Medical Solutions is recalling syngo.CT software version VA48A_SP5.5 for specific SOMATOM CT models due to scanning workflow interruptions and unexpected user notifications.

    Product
    syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2367-2019·2019-09-04

    Siemens Artis X-Ray Systems Recalled for Patient Table Cracks

    Siemens is recalling 17 Artis zee and Artis Q interventional X-ray systems because cracks in the patient table mainframe could cause the upper bed to detach, posing a hazard to patients and staff.

    Product
    Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number Artis zee biplane 10094141; Artis Q floor 10848280; Artis Q biplane 10848282; Artis Q.zen floor 10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2404-2019·2019-09-04

    Siemens SOMATOM go.Top CT Scanner Recall for Falling Injector Holder

    Siemens is recalling 12 SOMATOM go.Top CT scanners because the injector holder could fall off. The devices are distributed in 20 US states.

    Product
    SOMATOM go.Top; Models #11061640 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2402-2019·2019-09-04

    Siemens SOMATOM go.All CT Scanner Recall for Falling Injector Holder

    Siemens is recalling 10 SOMATOM go.All CT scanners because the injector holder could fall off. The units are distributed in 20 US states.

    Product
    SOMATOM go.All; Models #11061630 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2403-2019·2019-09-04

    Siemens SOMATOM go.All CT Scanner Injector Holder Recall

    Siemens Medical Solutions is recalling SOMATOM go.All CT scanners because the injector holder could fall off with the injector and storage box.

    Product
    SOMATOM go.All; Models #11061638 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2405-2019·2019-09-04

    Siemens SOMATOM go.Top CT Scanner Recall for Falling Injector Holder

    Siemens is recalling SOMATOM go.Top CT scanners because the injector holder could fall off with the injector and storage box.

    Product
    SOMATOM go.Top; Models #11061648 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2399-2019·2019-09-04

    Siemens SOMATOM go.Now CT Systems Recalled for Injector Holder Risk

    Siemens is recalling SOMATOM go.Now CT systems because the injector holder could fall off with the injector and storage box.

    Product
    SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
    Category
    Medical Device
    Distribution
    Distributed nationwide