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.

101–125 of 796

  • HighFDA (Devices)·Z-0119-2023·2022-11-02

    ARTIS pheno interventional x-ray system software defect prevents treatment continuation

    Siemens is recalling ARTIS pheno x-ray systems with VE10B software due to three potential software issues that may prevent continued treatment on the affected system, potentially requiring use of an alternate system.

    Product
    ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1645-2022·2022-09-07

    X-Ray Imaging System X-Ray Tube Hardware Defect Worldwide Recall

    Siemens has recalled Artis Q and Artis Q.zen X-ray imaging systems due to a potential X-ray tube hardware defect. In rare cases, if error detection fails, the system will not be able to release X-ray until shut down; 1,389 units are affected globally.

    Product
    Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1647-2022·2022-09-07

    Siemens Artis icono X-Ray Systems Recalled for Potential Hardware Failure

    Siemens has recalled Artis icono X-ray imaging systems due to a potential hardware issue affecting a specific lot of X-ray tubes. If the error detection mechanism fails, the system cannot release X-rays until it is shut down.

    Product
    Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1646-2022·2022-09-07

    X-ray imaging system hardware defect may prevent operation

    Siemens is recalling certain X-ray imaging systems due to a potential hardware issue with the error detection mechanism. In rare cases, this could prevent X-ray emission until system shutdown.

    Product
    Artis pheno- Model No. 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1558-2022·2022-08-24

    Sensis Signal Input Box recall for patient electrical leakage hazard with improper mounting

    Siemens recalls 399 units of AXIOM Sensis systems due to risk of patient electrical shock if the Signal Input Box mounting deviates from its default position.

    Product
    AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis 10764561
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1425-2022·2022-07-27

    Sensis diagnostic tool software may fail to display vital signs

    Siemens' Sensis diagnostic tool may lose communication and fail to display vital signs during initial patient exams or after inactivity. Software updates are required.

    Product
    Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1426-2022·2022-07-27

    Sensis Vibe Combo Device Recalled for Software Communication Failure

    The Sensis Vibe Combo diagnostic system may experience communication failure during patient procedures, causing vital signs data to be unavailable. The recall affects 13 units distributed across multiple U.S. states.

    Product
    Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2022·2022-07-13

    Imaging system software displays mirrored CT images during data loading

    Siemens imaging systems with syngo VE20 software may display CT images mirrored horizontally and vertically when loading Toshiba data, potentially causing misinterpretation of patient positioning and inappropriate treatment.

    Product
    syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1343-2022·2022-07-13

    Fluoroscopic X-Ray System Stand Movement May Be Blocked During Use

    Siemens Artis and Artis Q.zeego fluoroscopic X-ray systems may lose stand mobility if the robotic control system's BIOS battery discharges at startup. Field service is required to restore function.

    Product
    Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1342-2022·2022-07-13

    Siemens X-ray System Fan Wear May Cause Equipment Malfunction

    Siemens is recalling 88 Artis Icono X-ray systems in the U.S. due to increased fan wear that could lead to electrical failure and malfunction of the imaging system during operation.

    Product
    Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-1294-2022·2022-07-06

    Artis Pheno fluoroscopic system may lose video display signals

    Siemens Artis Pheno fluoroscopic X-ray systems may lose video signals from the Large Display during procedures. In rare cases, both transceivers could fail, affecting displays in the examination and control rooms.

    Product
    Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1245-2022·2022-06-15

    Siemens Artis icono Angiography Systems: Risk of Electric Shock from Grounding Failure

    Siemens is recalling 51 Artis icono biplane angiography systems due to a potential grounding failure that could allow electric shock if someone contacts metallic parts during use.

    Product
    Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1243-2022·2022-06-15

    Siemens Sensis Diagnostic Computer: Software Issues May Prevent Treatment Continuation

    Siemens has identified three potential software issues in Sensis programmable diagnostic computers. The issues may prevent treatment from continuing on the device, requiring patients to switch to alternate systems.

    Product
    Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1246-2022·2022-06-15

    Siemens Artis Icono Angiography Systems Pose Electric Shock Risk

    Siemens Artis icono angiography systems may pose electric shock risk if protective grounding is interrupted. Affected units sold nationwide; users should verify equipment grounding integrity.

    Product
    Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0997-2022·2022-05-04

    CT Scanner Software Update May Display Incorrect Laser Positioning Coordinates

    Siemens CT scanner imaging software upgraded to version VB60 may display incorrect laser offset coordinates during patient marking. Fourteen units are affected in the United States.

    Product
    syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0995-2022·2022-05-04

    CT Scanner Software Update May Display Incorrect Laser Offset Coordinates

    Siemens CT scanner software upgrade may cause incorrect laser offset coordinates to display during patient positioning. No injuries reported.

    Product
    syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1010-2022·2022-05-04

    Acuson 9vE4 Ultrasound Transducers Recalled for Potential Thermal Injury Risk

    Siemens is recalling 31 Acuson 9vE4 ultrasound transducers that may exceed thermal index limits, creating a potential risk of thermal injury. Affected units were distributed in US states and international locations.

    Product
    Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2022·2022-05-04

    Radiation therapy software update displays incorrect laser positioning

    Siemens syngo.via RT imaging software upgraded to VB60 automatically modifies laser configuration, potentially displaying incorrect laser offset coordinates during radiation therapy patient marking.

    Product
    syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2022·2022-05-04

    CT scanner software upgrade causes incorrect laser position display

    Siemens CT scanner software upgrade may display incorrect laser offset coordinates during patient marking. This defect affects 15 systems in the US across multiple states.

    Product
    syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0977-2022·2022-04-27

    Artis Q zeego X-ray system recalled for inadequate cooling risk

    Siemens is recalling 38 Artis Q zeego X-ray systems nationwide due to a cooling circuit malfunction that may prevent adequate cooling of the X-ray tube, triggering automatic system shutdown.

    Product
    Artis Q zeego, Model Number 10848283
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0986-2022·2022-04-27

    Diagnostic imaging system software malfunction may interrupt clinical procedures

    Siemens is recalling 35 Artis icono floor diagnostic imaging systems due to five potential software errors affecting equipment movements and detector control. The defects may limit functionality during procedures and could delay clinical treatment until the system is restarted.

    Product
    Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2022·2022-04-27

    CT Scanner Software Error May Cause Scanning Interruptions and Unexpected Radiation

    Siemens SOMATOM CT scanners with software syngo CT VA30A_SP4 may experience sporadic software errors causing scanning interruptions and potential unexpected radiation doses. 547 units affected nationwide.

    Product
    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0969-2022·2022-04-27

    Medical X-ray imaging system recalled for cooling circuit malfunction

    Siemens' Artis zee X-ray imaging systems may have inadequate cooling if the coolant level drops, potentially causing X-ray tube overheating. The system displays warnings and blocks X-ray operation to prevent equipment damage.

    Product
    Artis zee multi-purpose, Model Number 10094139
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0967-2022·2022-04-27

    Artis zee floor X-ray systems recalled for cooling system failure

    Siemens is recalling 305 Artis zee floor X-ray imaging systems because the cooling circuit may fail to maintain adequate coolant levels, potentially causing the X-ray tube to overheat. The system includes automatic safeguards that shut down X-ray operation if overheating is detected.

    Product
    Artis zee floor, Model Number 10094135
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0974-2022·2022-04-27

    Artis Q floor X-ray system cooling failure poses overheating risk

    Siemens is recalling 80 Artis Q floor X-ray systems nationwide due to a cooling circuit failure that may cause insufficient cooling of the X-ray tube, resulting in automatic system shutdown.

    Product
    Artis Q floor, Model Number 10848280
    Category
    Medical Device
    Distribution
    Distributed nationwide