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.

176–200 of 796

  • HighFDA (Devices)·Z-2404-2021·2021-09-08

    Siemens Artis Angiography Systems Software Error May Delay Clinical Treatment

    Certain Siemens Artis angiography systems with software version VD12 may fail to start up properly due to a software error, potentially delaying clinical imaging procedures. The issue affects specific units identified by serial number.

    Product
    Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2029-2021·2021-07-14

    ARTIS Angiography System Software Error Causes C-Arm Positioning Deviation

    A software error in ARTIS angiography systems can cause the C-arm to deviate from intended position by up to 22 cm during imaging procedures. Affected units require identification by serial number.

    Product
    ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1496-2021·2021-05-05

    Siemens Recalls Artis Angiography Systems Due to Belt Corrosion

    Siemens is recalling 3,320 Artis angiography systems in the US because belt corrosion may cause system failure or unintended C-Arm movement.

    Product
    Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433; AXIOM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1497-2021·2021-05-05

    Siemens Recalls ARTIS X-Ray Systems Due to Software Issue

    Siemens is recalling 133 ARTIS X-ray systems due to a potential software issue that may require terminating planned procedures.

    Product
    Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1495-2021·2021-05-05

    Siemens Artis zee X-Ray System Recalled for Cabling Abrasion

    Siemens Medical Solutions is recalling 772 Artis zee ceiling-interventional Fluoroscopic X-Ray Systems due to increased cabling abrasion that may limit functionality and disrupt clinical treatment.

    Product
    Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1434-2021·2021-04-28

    Siemens Sensis Systems Recalled for Windows Service Permission Vulnerability

    Siemens Medical Solutions is recalling Sensis and Sensis Vibe Hemo systems due to Windows Service Permission configuration risks that could expose sensitive information or allow data manipulation.

    Product
    Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 1100764
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1346-2021·2021-04-14

    Siemens Ysio X.pree Digital X-Ray System Recalled for Image Mismatch

    Siemens is recalling 12 Ysio X.pree digital X-ray systems because a software issue may display a previous patient's image during recovery, potentially impacting diagnosis.

    Product
    Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1330-2021·2021-04-07

    Siemens ACUSON Sequoia Ultrasound Systems Recalled for Incorrect Delivery Date Calculations

    Siemens is recalling 1,172 ACUSON Sequoia ultrasound systems because a software error may calculate incorrect Estimated Dates of Delivery, potentially influencing clinical decisions.

    Product
    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
    Category
    Medical Device
    Distribution
    44 states
  • ModerateFDA (Devices)·Z-1288-2021·2021-03-31

    Siemens Recalls 29 Interventional Fluoroscopic X-Ray Systems for Shutdowns

    Siemens is recalling 29 interventional fluoroscopic X-ray systems because the power supply may cause the computer to shut down unexpectedly.

    Product
    Interventional Fluoroscopic X-Ray System - Product Usage: developed 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-1253-2021·2021-03-24

    Siemens SOMATOM CT Software Recall for Workflow Interruptions

    Siemens is recalling specific software versions for SOMATOM CT systems due to sporadic errors that may interrupt scanning workflows and delay diagnosis.

    Product
    Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1173-2021·2021-03-10

    Siemens Sensis Vibe Systems Recalled for Potential System Freezes

    Siemens is recalling 37 Sensis Vibe systems in the US because they may sporadically freeze during operation or idle, preventing user interaction.

    Product
    Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1144-2021·2021-03-03

    Siemens ARTIS Icono Biplane and Floor Systems Recalled for Software Errors

    Siemens is recalling 41 ARTIS Icono systems with software version VE20B due to misleading error messages and manual gaps that may cause procedure termination.

    Product
    ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0656-2021·2021-01-20

    Siemens Artis Medical Imaging Systems Recalled for Radiation Safety Defect

    Siemens is recalling Artis zee, Artis Q, and Artis Pheno systems because the Air Kerma Rate can exceed regulatory limits when frame rates are increased during continuous release.

    Product
    Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0806-2021·2021-01-20

    Siemens Uroskop Omnia Max X-ray System Recalled for Support Arm Risk

    Siemens is recalling 281 Uroskop Omnia Max X-ray systems because the monitor support arm may become dislodged after intense, long-term use.

    Product
    Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0805-2021·2021-01-20

    Siemens Uroskop Omnia X-ray System Recalled for Support Arm Risk

    Siemens is recalling six Uroskop Omnia X-ray systems because the monitor support arm may become dislodged after intense, long-term use.

    Product
    Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0771-2021·2021-01-20

    Siemens SOMATOM CT Scanner Software Recall for Scan Parameter Issues

    Siemens is recalling specific SOMATOM CT scanner systems due to a software issue that may prevent scan cancellation and reloading, potentially delaying diagnosis or requiring patient rescans.

    Product
    SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0469-2021·2020-11-25

    Siemens Artis X-Ray Systems Recalled for Overvoltage Protection Defect

    Siemens is recalling 26 Artis X-ray systems worldwide because incorrect diodes may fail to protect against overvoltage, potentially causing system malfunction.

    Product
    Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0400-2021·2020-11-11

    Siemens ARTIS Icono X-Ray System Recalled for Software Misalignment

    Siemens is recalling ARTIS Icono X-ray systems due to a software defect that may cause inaccurate image overlays, potentially leading to patient danger.

    Product
    ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: 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 obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0298-2021·2020-11-04

    Siemens Artis one Fluoroscopic X-Ray Systems Recalled for Monitor Malfunction

    Siemens Medical Solutions is recalling 22 Artis one systems because the examination room monitor may become intermittently dysfunctional, causing display issues.

    Product
    Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0108-2021·2020-10-21

    Siemens Artis zee and Q Systems Recalled for Collision Risk

    Siemens Medical Solutions is recalling Artis zee and Artis Q systems because a software defect may cause the equipment to collide with room fixtures or patients.

    Product
    Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN B
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3025-2020·2020-10-07

    Siemens CT Software Recall for Workflow Interruptions and Diagnostic Delays

    Siemens Medical Solutions is recalling syngo.CT software versions VB20 and VB20_SP1 for 767 CT systems due to sporadic workflow interruptions that may delay diagnosis or require patient rescans.

    Product
    Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confiden
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3005-2020·2020-09-30

    Siemens Syngo.via RT Image Suite Software Recall for Calibration Offset Error

    Siemens is recalling Syngo.via RT Image Suite software due to a calibration offset error that could result in incorrect radiation dose or dose applied to the wrong location.

    Product
    Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2934-2020·2020-09-09

    Siemens Symbia S and T Series SPECT Systems Recalled for Detector Motion

    Siemens Medical Solutions is recalling 412 Symbia S and T Series SPECT systems due to a defect that may cause unintended slow motion of the detectors.

    Product
    Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: 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 u
    Category
    Medical Device
    Distribution
    Distributed nationwide