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.

76–100 of 796

  • HighFDA (Devices)·Z-2359-2023·2023-08-16

    Siemens ARTIS Icono Biplane Angiography Systems Thermal Cable Connector Defect

    Siemens recalls ARTIS icono biplane angiography systems with defective cable connectors that may cause thermal overload, burning smell, and loss of imaging functionality during clinical procedures.

    Product
    ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2256-2023·2023-08-09

    Siemens Pro.specta Emission CT Systems Sensor Issue Reduces Image Resolution

    Siemens Pro.specta CT imaging systems may produce reduced image quality due to sensors triggering earlier than expected, potentially affecting diagnostic accuracy. Affected units were distributed across the US and internationally.

    Product
    The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2240-2023·2023-08-02

    Mobile X-ray System with Faulty Glue Assembly May Pose Electric Shock Hazard

    Siemens Mobile X-ray systems may have incorrect glue on the tank cover assembly, which could fall off and allow liquid ingress, creating electric shock risk. The recall affects 9 units distributed in the US and internationally.

    Product
    Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. Material #11515088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1480-2023·2023-05-31

    Fluoroscopic Imaging System May Display Incorrect Radiation Dose Measurements

    Siemens Luminos dRF Max fluoroscopic imaging systems may occasionally display incorrect radiation dose measurements during certain operating conditions. The manufacturer states the error does not affect diagnosis or workflow.

    Product
    Luminos dRF Max (VE10, VF10, VF11)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1479-2023·2023-05-31

    Fluoroscopic imaging system may display incorrect radiation dose readings

    Siemens Luminos Agile Max fluoroscopic imaging systems may occasionally display incorrect radiation dose information under certain unlikely circumstances. The manufacturer states there is no impact on clinical workflow or diagnosis. The error only occurs in systems with a second overhead X-ray tube.

    Product
    Luminos Agile Max (VE10, VF10, VF11)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1481-2023·2023-05-31

    LUMINOS Lotus Max fluoroscopic system recalled for sporadic measurement errors

    LUMINOS Lotus Max fluoroscopic systems may sporadically display incorrect radiation dose measurements. The error only occurs with secondary X-ray tubes and does not affect diagnosis or workflow.

    Product
    LUMINOS Lotus Max (VF11)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1498-2023·2023-05-10

    Angiography System C-Arm Positioning Malfunction May Cause Patient Injury

    Siemens ARTIS pheno angiography systems may misposition the C-arm by 5-10 millimeters when using the reference image positioning function, risking patient and staff crushing injuries. The device may also display inaccurate imaging overlays, potentially causing vessel perforation.

    Product
    ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1469-2023·2023-05-03

    Angiography system display malfunction affects diagnostic imaging capability

    Siemens recalls the ARTIS one angiography system due to a hybrid cable display issue that may prevent image function on examination room monitors. Four US units are affected.

    Product
    ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1311-2023·2023-04-05

    Fluoroscopic X-Ray System Recalled for Unintended Table Movement Risk

    Siemens ARTIS pheno X-ray systems may experience unintended table movement that the system fails to detect, risking injury to patients, staff, or operators. The FDA is recalling 141 affected units nationwide.

    Product
    ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1164-2023·2023-03-01

    Luminos Agile Diagnostic Imaging System Collision Risk Recall

    Siemens recalls Luminos Agile imaging systems that may collide with ceilings or walls due to default configuration settings, potentially causing serious injury to staff or patients.

    Product
    Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1166-2023·2023-03-01

    Diagnostic Imaging System Recalled for Potential Ceiling and Wall Collision Risk

    Siemens Luminos dRF diagnostic imaging system is being recalled nationwide due to potential collision with ceilings, walls, or objects caused by default room configuration parameters. Collisions could result in serious injury to patients or staff.

    Product
    Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1165-2023·2023-03-01

    Diagnostic imaging system recalled for collision risk from default settings

    Siemens Luminos Agile Max diagnostic imaging systems recalled due to default configuration parameters allowing collision with room structures, risking serious injury to staff or patients.

    Product
    Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1168-2023·2023-03-01

    Diagnostic imaging system recalled due to ceiling and wall collision risk

    Siemens Uroskop Omnia Max imaging systems are recalled due to collision risk with ceilings, walls, or objects caused by default configuration settings. The systems may move dangerously, potentially injuring staff or patients.

    Product
    Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1167-2023·2023-03-01

    Diagnostic imaging system recalled for collision risk from default settings

    Siemens Luminos dRF Max diagnostic imaging systems are being recalled due to a risk of collision with ceiling, walls, or nearby objects caused by default room configuration settings. This could result in serious injury to staff or patients.

    Product
    Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2023·2023-02-22

    Potential Gantry Locking Mechanism Defect in SIEMENS Biograph mCT PET Scanners

    The SIEMENS Biograph mCT PET scanner has a potential issue with the locking mechanism that secures the gantry. Six units distributed worldwide including the US, Japan, Chile, and Australia are affected.

    Product
    SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1134-2023·2023-02-22

    SIEMENS Biograph Horizon 3R Mobile PET gantry locking mechanism defect

    Siemens is recalling the Biograph Horizon 3R Mobile PET/CT system due to a potential failure of the locking mechanism that secures the PET gantry in its scanning or service position. The system has been distributed worldwide.

    Product
    SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1136-2023·2023-02-22

    Siemens Biograph Vision PET Scanner Gantry Locking Mechanism Recall

    Siemens recalls Biograph Vision PET scanners worldwide for a potential defect in the gantry locking mechanism that secures the equipment during scanning and service.

    Product
    SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2023·2023-02-08

    Siemens Fluoroscopic X-ray Systems Risk of Boot Failure After Shutdown

    Certain Siemens fluoroscopic X-ray systems may only boot into backup mode after an abrupt shutdown, preventing full operation. This could necessitate cancelling or switching to alternative treatment systems.

    Product
    System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 108
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1003-2023·2023-02-01

    Siemens myNeedle Guide Software: Swapped Orientation Labels in CT Systems

    Siemens myNeedle Guide software for CT imaging systems has swapped orientation labels in axial images, which could lead to misorientation during guided procedures. The software requires correction.

    Product
    Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.Now Model 11061610 NA* SOMATOM go.Now Model 11061618 NA* SOMATOM go.Up Model 11061620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0956-2023·2023-01-25

    ARTIS medical imaging systems recalled for mechanical connection failure

    Siemens ARTIS pheno and ARTIS icono imaging systems are recalled because the mechanical connection between the tabletop and table base may fail. The recall affects 550 units distributed worldwide.

    Product
    ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1001-2023·2023-01-25

    Patient table footrest may detach from AXIOM Luminos Agile

    Siemens Medical Solutions is recalling the AXIOM Luminos Agile patient table because the footrest may detach during use, creating a potential injury risk.

    Product
    AXIOM Luminos Agile
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1002-2023·2023-01-25

    X-ray imaging system footrests may detach from patient tables

    Siemens Luminos X-ray imaging systems may have a footrest that detaches from the patient table during use. The manufacturer is recalling 886 units distributed worldwide.

    Product
    Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1000-2023·2023-01-25

    Medical X-ray equipment patient table footrests recalled due to detachment risk

    Siemens recalls four fluoroscopy and radiographic imaging equipment models worldwide because patient table footrests may detach during clinical use, potentially causing patient injury.

    Product
    AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0775-2023·2023-01-11

    Programmable Diagnostic Computer Software Update Addresses Crash Errors

    Siemens is updating software in 638 Programmable Diagnostic Computers distributed in the US to fix four software errors that could crash the device or corrupt password storage, potentially delaying diagnostics.

    Product
    Programmable Diagnostic Computer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0472-2023·2022-12-21

    Linear accelerator software addresses potential wrong-site treatment risk

    Siemens linear accelerator systems may allow users to select the wrong treatment site, potentially delivering radiation to the wrong location. The FDA classified this Class II recall affecting 8 units across seven U.S. states.

    Product
    ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide