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.

126–150 of 796

  • HighFDA (Devices)·Z-0972-2022·2022-04-27

    X-ray Imaging System May Fail to Cool Tube Properly

    Siemens Artis zee biplane MN X-ray systems may have inadequate cooling in the X-ray tube circuit, causing automatic system shutdown during operation. Seven affected systems are distributed nationwide.

    Product
    Artis zee biplane MN, Model Number 10094143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0979-2022·2022-04-27

    Siemens Artis Q.zen ceiling system recall: inadequate X-ray tube cooling risk

    Siemens recalls 81 Artis Q.zen ceiling imaging systems distributed nationwide due to risk of inadequate X-ray tube cooling if coolant levels fall below a critical threshold, potentially triggering system shutdown.

    Product
    Artis Q.zen ceiling, Model Number 10848354
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0976-2022·2022-04-27

    Artis Q biplane X-ray systems cooling failure may prevent adequate tube cooling

    Siemens is recalling 269 Artis Q biplane X-ray systems due to potential coolant level drops that may prevent the X-ray tube from cooling adequately, triggering automatic system shutdown.

    Product
    Artis Q biplane, Model Number 10848282
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0985-2022·2022-04-27

    Medical imaging system software errors may delay treatment procedures

    Siemens Artis icono biplane diagnostic imaging systems may experience software errors affecting block movements and detector rotation, potentially delaying treatment until the system is restarted.

    Product
    Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0970-2022·2022-04-27

    Siemens Artis zee biplane X-ray system cooling defect recall

    Siemens is recalling 373 Artis zee biplane X-ray diagnostic systems due to a cooling circuit defect that could prevent adequate tube cooling. When the coolant level drops, the system may overheat and shut down imaging capabilities.

    Product
    Artis zee biplane, Model Number 10094141
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2022·2022-04-27

    Medical device X-ray imaging system recalled for cooling failure

    Siemens Medical Solutions is recalling its Artis Q.zen X-ray imaging system due to a coolant circulation defect that may cause insufficient tube cooling and system shutdown.

    Product
    Artis Q.zen floor, Model Number 10848353
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0975-2022·2022-04-27

    X-ray Imaging System Coolant Deficiency May Disable Equipment Operation

    The Artis Q X-ray system may fail to adequately cool the X-ray tube if coolant levels drop, causing the system to disable imaging and display error messages. 418 systems are affected nationwide.

    Product
    Artis Q ceiling, Model Number 10848281
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0987-2022·2022-04-27

    Siemens Artis pheno diagnostic imaging system software malfunction recall

    Siemens Medical Solutions is recalling 20 Artis pheno diagnostic imaging systems nationwide due to software errors in block movement and detector rotation functions. The malfunction may limit device functionality and delay clinical treatment until the system restarts.

    Product
    Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0973-2022·2022-04-27

    Artis zeego X-ray imaging system recalled for insufficient cooling

    Siemens is recalling 183 Artis zeego X-ray imaging systems due to a cooling system defect that may prevent adequate X-ray tube cooling, triggering automatic system shutdown.

    Product
    Artis zeego, Model Number 10280959
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0971-2022·2022-04-27

    X-Ray Imaging System Cooling Circuit Failure Recall

    Siemens is recalling Artis zee floor MN X-ray systems due to a potential cooling circuit malfunction. If coolant drops below adequate levels, the X-ray tube may not cool properly and the system will automatically shut down.

    Product
    Artis zee floor MN, Model Number 10094142
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0968-2022·2022-04-27

    X-ray Imaging System Cooling Failure May Cause Tube Overheating

    Siemens Artis zee ceiling X-ray systems may fail to cool the X-ray tube if the coolant level drops. The system will automatically block X-ray emissions and display warning messages to prevent equipment damage.

    Product
    Artis zee ceiling, Model Number 10094137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0980-2022·2022-04-27

    Artis Q.zen Biplane X-ray Systems Coolant Level Failure Recall

    Siemens is recalling 69 Artis Q.zen biplane systems where coolant levels may drop sufficiently to prevent adequate X-ray tube cooling, triggering automatic shutdown safeguards.

    Product
    Artis Q.zen biplane, Model Number 10848355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2022·2022-04-13

    SPECT/CT Imaging Systems Recalled Due to Defective Balancing Weight Bolts

    Siemens is recalling seven Symbia Intevo SPECT/CT imaging systems due to a quality defect in the bolts that secure the CT balancing weights, which could create a safety issue.

    Product
    Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0730-2022·2022-04-13

    X-ray system displays incorrect collimation area information

    The YSIO X.Pree x-ray system's user interface displays incorrect collimation information during image acquisition. While actual collimation functions correctly, the display does not match preset parameters, potentially confusing operators.

    Product
    YSIO X.Pree
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0841-2022·2022-04-06

    Radiographic system software error may cause unintended tube stand movement

    Siemens is recalling 70 Ysio radiographic systems due to a software error that may cause unintended tube stand movement and create collision risk.

    Product
    Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0748-2022·2022-03-23

    Diagnostic ultrasound system ACUSON Juniper fails to save study clips

    The ACUSON Juniper ultrasound system's clip storage function fails when the disk is full, potentially delaying treatment during critical imaging procedures. Healthcare facilities using this system should contact Siemens for support.

    Product
    Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0547-2022·2022-02-09

    Ultrasound System Software Calculation Error in Siemens ACUSON Sequoia

    Software error in certain Siemens ACUSON Sequoia ultrasound systems causes measurement values to be overestimated, potentially resulting in patient misdiagnosis.

    Product
    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2022·2022-02-02

    Diagnostic Imaging Angiography System Software Defects Recalled by Siemens

    Siemens is recalling 23 Artis icono angiography systems due to four software defects that could disable imaging, corrupt images, and cause unexpected shutdowns during patient procedures.

    Product
    Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2022·2022-02-02

    Artis icono diagnostic imaging system software defects recalled nationwide

    Siemens is recalling 72 units of Artis icono biplane diagnostic imaging systems nationwide due to four software issues that could disable x-ray capability, corrupt diagnostic images, or cause unexpected shutdowns during procedures.

    Product
    Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0515-2022·2022-02-02

    Siemens Diagnostic Angiography System Recalled for Multiple Software Defects

    Siemens is recalling its Artis pheno diagnostic angiography system (12 units) due to four software defects that may prevent imaging, corrupt images, or cause unintended shutdowns during clinical use.

    Product
    Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0499-2022·2022-01-26

    FDA Recalls Sensis Cardiac Diagnostic Systems for Software Measurement Error

    Sensis cardiac diagnostic systems used in catheterization and electrophysiology procedures are recalled due to a software error (version VD12A) that can temporarily disable cardiac output measurement. No illnesses have been reported.

    Product
    1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0472-2022·2022-01-19

    CT Scanner Software Defect May Degrade Image Quality Nationwide

    Siemens SOMATOM Confidence CT scanners with software version VB20_SP5 may experience degraded head image quality, creating a potential risk of misdiagnosis. The recall affects 108 units distributed nationwide.

    Product
    SOMATOM Confidence -Computed tomography systems Model 10590100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2022·2022-01-19

    CT Scanner Software Defect May Degrade Image Quality

    Software version VB20_SP5 in certain Siemens CT scanners may degrade head image quality, increasing misdiagnosis risk. The recall affects 794 units distributed nationwide.

    Product
    SOMATOM Definition AS-Computed tomography system Model 8098027
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0474-2022·2022-01-19

    Computed Tomography System Software May Degrade Head Image Quality

    Siemens SOMATOM Edge Plus CT systems running software version VB20_SP5 may produce degraded head images, potentially leading to patient misdiagnosis.

    Product
    SOMATOM Edge Plus-Computed tomography system Model 1026700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0475-2022·2022-01-19

    CT Scanner Software Update Causes Head Image Quality Degradation

    Siemens SOMATOM Definition Edge CT scanners with software version VB20_SP5 may produce degraded head images, increasing the risk of patient misdiagnosis. Devices have been distributed nationwide.

    Product
    SOMATOM Definition Edge -Computed tomography system Model 10590000
    Category
    Medical Device
    Distribution
    Distributed nationwide