ARTIS icono biplane 11327600Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 04056869063317), received between Sep 2, 2020 and Sep 29, 2026 — classified as 2 deaths, 2 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 reports).

15 FDA recall records name this device's identifier, 14 still open.

9 other recalls cover devices cleared under the same FDA submission (K190768, K220432, K230950, K241572, K254173); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 20, 2026Class IIOpen, Classified

   Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

   Z-2641-2026 · Root cause: Software design · Recall details · FDA record ↗

2. Mar 10, 2026Class IIOpen, Classified

   During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.

   Z-1653-2026 · Root cause: Radiation Control for Health and Safety Act · Recall details · FDA record ↗

3. Mar 9, 2026Class IIOpen, Classified

   During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

   Z-2206-2026 · Root cause: Radiation Control for Health and Safety Act · Recall details · FDA record ↗

4. May 15, 2025Class IIOpen, Classified

   In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.

   Z-2020-2025 · Root cause: Radiation Control for Health and Safety Act · Recall details · FDA record ↗

5. Jun 26, 2024Class IIOpen, Classified

   A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

   Z-2242-2024 · Root cause: Software design · Recall details · FDA record ↗

6. Jun 26, 2024Class IIOpen, Classified

   A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

   Z-2241-2024 · Root cause: Software design · Recall details · FDA record ↗

7. Jun 26, 2024Class IIOpen, Classified

   A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

   Z-2240-2024 · Root cause: Software design · Recall details · FDA record ↗

8. Jun 19, 2023Class IIOpen, Classified

   Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system

   Z-2359-2023 · Root cause: Process control · Recall details · FDA record ↗

9. Dec 16, 2022Class IIOpen, Classified

   Mechanical connection between the tabletop and table base may be lost.

   Z-0956-2023 · Root cause: Device Design · Recall details · FDA record ↗

10. Aug 10, 2022Class IIOpen, Classified

    Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.

    Z-1647-2022 · Root cause: Device Design · Recall details · FDA record ↗

11. May 20, 2022Class IIOpen, Classified

    During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.

    Z-1342-2022 · Root cause: Process control · Recall details · FDA record ↗

12. Apr 11, 2022Class IIOpen, Classified

    if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm

    Z-1245-2022 · Root cause: Device Design · Recall details · FDA record ↗

13. Feb 25, 2022Class IIOpen, Classified

    Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed

    Z-0985-2022 · Root cause: Software Design Change · Recall details · FDA record ↗

14. Feb 25, 2022Class IIOpen, Classified

    After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in inappropriate treatment, even if the incorrect visualization is obvious.

    Z-1339-2022 · Root cause: Software design · Recall details · FDA record ↗

15. Oct 12, 2021Class IITerminated

    Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option

    Z-0516-2022 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932031 ↗
• MalfunctionSep 28, 2026Computer Software Problem

  Siemens Healthineers became aware of a malfunction involving an ARTIS icono biplane system operating with software version VE50B. During system use, the messages "Limited stand/table movement, SC" and "Collision detection disabled, SC - Move carefully" were displayed. Subsequently, all system movements became unavailable. The system recovered after a power cycle (system off/on). No patient injury or other health consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916064 ↗
• MalfunctionSep 28, 2026Computer Software Problem

  Siemens Healthineers became aware of a malfunction involving an ARTIS icono biplane system operating with software version VE50B. During system use, the messages "Limited stand/table movement, SC" and "Collision detection disabled, SC - Move carefully" were displayed. Subsequently, all system movements became unavailable. The system recovered after a power cycle (system off/on), as described in the user manual for this condition. No patient injury or other health consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915650 ↗
• MalfunctionSep 28, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914552 ↗
• MalfunctionSep 25, 2026Activation Problem

  Siemens became aware of a malfunction that occurred while operating the ARTIS icono biplane system. During an interventional patient procedure, no system movement was possible. The procedure was continued using the same system. We have no indications of any adverse effects on the health status of the involved patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895763 ↗
• MalfunctionMay 29, 2026Mechanical Problem

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE SYSTEM. DURING A STROKE PROCEDURE, NO STAND OR TABLE MOVEMENTS WERE POSSIBLE. THE USER REPORTED A DELAY IN TREATMENT, HOWEVER, THE PROCEDURE WAS CONTINUED AND COMPLETED USING THE SAME SYSTEM. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25332096 ↗
• MalfunctionMay 18, 2026Radiation Output Failure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, NO X-RAY RELEASE WAS NOT POSSIBLE. THE PROCEDURE WAS CONTINUED ON AN ALTERNATIVE SYSTEM. NO ADVERSE HEALTH CONSEQUENCES WERE COMMUNICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25202660 ↗
• MalfunctionApr 10, 2026No Apparent Adverse Event

  IT WAS REPORTED TO SIEMENS HEALTHINEERS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE. DURING PROCEDURE, THE SYSTEM WAS RESTARTED. HOWEVER, STAND MOVEMENTS WERE NOT POSSIBLE AND A STAND/TABLE ERROR WAS DISPLAYED AFTER THE RESTART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844731 ↗
• MalfunctionApr 9, 2026No Apparent Adverse Event

  IT WAS REPORTED TO SIEMENS HEALTHINEERS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE. BEFORE THE PROCEDURE, STAND MOVEMENTS WERE NOT POSSIBLE AND A STAND/TABLE ERROR WAS DISPLAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832350 ↗
• MalfunctionApr 9, 2026No Apparent Adverse Event

  IT WAS REPORTED TO SIEMENS HEALTHINEERS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE. AFTER SYSTEM STARTED UP, STAND MOVEMENTS WERE NOT POSSIBLE AND A STAND/TABLE ERROR WAS DISPLAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830224 ↗
• MalfunctionMar 20, 2026Positioning Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE SYSTEM. DURING AN EMERGENCY PROCEDURE, MOTORIZED STAND MOVEMENT OF THE GANTRY BASE ROTATION AXLE WAS NO LONGER POSSIBLE AND THE SYSTEM MESSAGE "MOVEMENT: END REACHED" WAS DISPLAYED TO THE USER. AS A RESULT, THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647798 ↗
• MalfunctionFeb 5, 2026Mechanical Problem

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, SYSTEM MOVEMENTS WERE NOT AVAILABLE. THE PATIENT HAD TO BE MOVED, AND THE PROCEDURE WAS COMPLETED ON AN ALTERNATIVE SYSTEM. NO HEALTH CONSEQUENCES FOR THE INVOLVED PATIENT WERE COMMUNICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268856 ↗
• MalfunctionDec 23, 2025Insufficient Device Problem Information; Device Handling Problem; Insufficient Device Problem Information; Device Handling Problem

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE UNIT. DURING AN EMERGENCY PATIENT PROCEDURE, NO SYSTEM MOVEMENTS WERE AVAILABLE. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT. HOWEVER, ADDITIONAL INFORMATION WAS PROVIDED THAT THE USER WAS ABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876571 ↗
• MalfunctionDec 5, 2025Break; Break

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED ON THE ARTIS ICONO BIPLANE UNIT. THE ARM OF RADIATION PROTECTION SHIELD WAS REPORTED TO BE DAMAGED. DETAILED CLARIFICATIONS OF THIS EVENT ARE CURRENTLY ONGOING; THEREFORE THE EVENT IS REPORTED IN DOUBT. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728116 ↗
• MalfunctionNov 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE SYSTEM. DURING A PATIENT PROCEDURE, THE SIDE CONTROLS WERE FLASHING. ON NOVEMBER 17TH, 2025, ADDITIONAL INFORMATION WAS RECEIVED THAT THE EMERGENCY STOP BUTTON WAS PERMANENTLY ACTIVATED DURING THE PROCEDURE. THIS RESULTED IN PATIENT BEING MOVED TO PROCEED WITH THE PROCEDURE ON AN ALTERNATE UNIT. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618868 ↗
• MalfunctionJun 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, NO STAND MOVEMENTS WERE AVAILABLE. THE PATIENT WAS RELOCATED, AND THE PROCEDURE WAS COMPLETED ON AN ALTERNATE UNIT. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320979 ↗
• MalfunctionApr 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT NO MOVEMENT WAS POSSIBLE. THE PROCEDURE WAS CONTINUED AND FINISHED USING AN ALTERNATE SYSTEM. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT. SIEMENS HEALTHINEERS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO INVESTIGATE THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908983 ↗
• MalfunctionJan 22, 2025Communication or Transmission Problem; Communication or Transmission Problem

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, NO TABLE MOVEMENT WAS NOT POSSIBLE. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT WAS RELOCATED TO A DIFFERENT MEDICAL FACILITY FOR FURTHER MEDICAL TREATMENT. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207958 ↗
• DeathNov 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED BY ITS SERVICE ORGANIZATION THAT AN EVENT OCCURRED DURING AN ACUTE STROKE INTERVENTIONAL PROCEDURE. DURING THE PROCEDURE, THE USER REPORTS THAT THE SYSTEM MALFUNCTIONED, AND NO X-RAY WAS POSSIBLE. THE USER STATES THE PATIENT MOST LIKELY RECEIVED BRAIN DAMAGE DUE TO THE TREATMENT DELAY; HOWEVER, THIS IS YET TO BE CONFIRMED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION AND DISPATCHED A CUSTOMER SERVICE ENGINEER TO THE SITE IN ORDER TO INVESTIGATE THE REPORTED MALFUNCTION.

  Patient problems: Brain Injury; Insufficient Information

  MAUDE report 20695442 ↗
• MalfunctionOct 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  SIEMENS HEALTHINEERS WAS INFORMED BY ITS SERVICE ORGANIZATION ABOUT AN ISSUE WITH THE ARTIS ICONO BIPLANE SYSTEM. THE DISPLAY CEILING SUSPENSION SUPPORT BROKE AND PARTIALLY DETACHED FROM THE CEILING. THERE WAS NO REPORT OF ANY ADVERSE HEALTH EFFECTS TO THE PATIENT, USERS, OR THIRD PARTIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20501052 ↗
• MalfunctionMay 20, 2024Radiation Output Failure; Radiation Output Failure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER WAS UNABLE TO RELEASE X-RAY AND THE PATIENT WAS RELOCATED TO AN ALTERNATE UNIT. HOWEVER, THE PATIENT'S CONDITION DETERIORATED, AND THE PROCEDURE WAS EVENTUALLY ABORTED. IT WAS LATER REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSAL RELATIONSHIP BETWEEN THE SYSTEM FAILURE AND THE PATIENT¿S CONDITION IS UNKNOWN AT THIS POINT IN TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 19351228 ↗
• MalfunctionApr 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE UNIT. DURING AN INTERVENTIONAL PROCEDURE, NO SYSTEM MOVEMENTS WERE POSSIBLE. THE PATIENT HAD TO BE RELOCATED TO A DIFFERENT HOSPITAL TO COMPLETE THE PROCEDURE. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19104891 ↗
• MalfunctionMar 5, 2024Radiation Output Problem; Radiation Output Failure; Radiation Output Problem; Radiation Output Failure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE UNIT. DURING A PATIENT PROCEDURE, THE USER RELEASED FLUORO A FOR APPROXIMATELY 2-3 SECONDS AND THE RADIATION DOSE WAS HIGHER THAN EXPECTED WITH IMAGE QUALITY BEING DIFFERENT AS WELL. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION ABOUT THIS SYSTEM FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836590 ↗
• InjuryFeb 23, 2024Loss of Data; Loss of Data

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE SYSTEM. INFORMATION WAS REPORTED TO SIEMENS ON (B)(6) 2024, THAT A PATIENT WAS ADMITTED TO THE HOSPITAL WITH A POTENTIAL STROKE. ACCORDING TO THE PHYSICIAN, THE PATIENT WAS NOT IN A LIFE-THREATENING CONDITION. DURING EXAMINATION IT WAS DETERMINED THAT THE PATIENT WAS SUFFERING FROM A VASCULAR MALFORMATION IN THE BRAIN THAT WAS CAUSING MASSIVE BLEEDING. THE USER TOOK 3D IMAGES FOR A NEUROSURGICAL OR, HOWEVER, THE IMAGES COULD NOT BE FOUND ON THE MACHINE, RESULTING IN A SYSTEM DELAY. THE UNIT WAS REBOOTED, AND THE PATIENT WAS RE-SCANNED AND TAKEN INTO THE OR. THE SURGERY WAS SUCCESSFUL AND 90% OF THE VASCULAR MALFORMATION WAS EMBOLIZED. THE PATIENT IS CURRENTLY INTUBATED IN THE INTENSIVE CARE UNIT. DUE TO THE VASCULAR MALFORMATION IN THE BRAIN CAUSING MASSIVE HEMORRHAGE IN THE LEFT CENTRAL REGION OF THE BRAIN, THE PATIENT HAS RIGHT-SIDED PARALYSIS AND WILL REMAIN IN A HANDICAPPED STATE. ACCORDING TO THE TREATING PHYSICIAN, THE PATIENT¿S HEALTH OUTCOME IS NOT RELATED TO THE SYSTEM DELAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18767203 ↗
• MalfunctionFeb 9, 2024Electrical /Electronic Property Problem; Insufficient Device Problem Information; Electrical /Electronic Property Problem; Insufficient Device Problem Information

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE SYSTEM. DURING AN EMERGENCY PROCEDURE, THE SYSTEM REPEATEDLY WENT INTO BYPASS MODE. THE PATIENT WAS MOVED TO A DIFFERENT ROOM AND THE PROCEDURE WAS COMPLETED ON AN ALTERNATE UNIT. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675886 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190768, K220432, K230950, K241572, K254173. One submission often covers many models, so check the product and lot details in each record.

• Z-2642-2026 · May 20, 2026 · Open, Classified
  ARTIS icono ceiling. Model Number: 11328100.
• Z-2643-2026 · May 20, 2026 · Open, Classified
  ARTIS icono floor. Model Number: 11327700.
• Z-1814-2026 · Mar 12, 2026 · Open, Classified
  ARTIS Pheno VE30A and VE40A, Model 10849000
• Z-2205-2026 · Mar 9, 2026 · Open, Classified
  ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
• Z-2529-2025 · Aug 12, 2025 · Open, Classified
  Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
• Z-2021-2025 · May 15, 2025 · Open, Classified
  interventional fluoroscopic x-ray system
• Z-2022-2025 · May 15, 2025 · Open, Classified
  interventional fluoroscopic x-ray system
• Z-2360-2023 · Jun 19, 2023 · Open, Classified
  ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700
• Z-1246-2022 · Apr 11, 2022 · Open, Classified
  Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700