ARCADIS Avantic 10143408Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04056869009001), received between Jul 6, 2020 and Jun 22, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Radiation Output Failure” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2022Radiation Output Problem; Radiation Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARCADIS AVANTIC GEN 2 SYSTEM. THE MEDICAL TEAM ALERTED SIEMENS OF A TOO HIGH DOSE RATE FOLLOWING A SITE VISIT. AT THIS TIME, WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF ANY PATIENT OR USER INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14771735 ↗
• MalfunctionDec 13, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARCADIS AVANTIC GEN 2 SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE IMAGES WERE OVER-EXPOSED. 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. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12982572 ↗
• MalfunctionDec 9, 2021Failure to Transmit Record; Failure to Transmit Record

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARCADIS AVANTIC GEN 2 SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED A 3-5 SECOND DELAY ON THE IMAGES FROM THE C-ARM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967961 ↗
• MalfunctionFeb 10, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARCADIS AVANTIC GEN 2 SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE C-ARM WOULD MOVE UP BUT NOT BACK DOWN. 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. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307962 ↗
• MalfunctionJan 26, 2021Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARCADIS AVANTIC GEN 2 SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT NO X-RAY WAS POSSIBLE. 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. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11228650 ↗
• MalfunctionNov 12, 2020Computer Software Problem; Battery Problem; Operating System Becomes Nonfunctional; Computer Software Problem; Battery Problem; Operating System Becomes Nonfunctional

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARCADIS AVANTIC GEN 2 SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE IMAGE PROCESSING PC CRASHED AND THE PROCEDURE START WAS DELAYED. 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. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10828716 ↗
• MalfunctionJul 6, 2020Use of Device Problem; Radiation Output Failure; Use of Device Problem; Radiation Output Failure

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WITH THE ARCADIS AVANTIC GEN2 UNIT. NO X-RAY WAS AVAILABLE DURING AN INTERVENTIONAL PROCEDURE. THE PATIENT HAD TO BE MOVED AND THE EXAM WAS SUCCESSFULLY COMPLETED ON ALTERNATIVE SYSTEM. THERE ARE NO INJURIES ATTRIBUTED TO THIS INCIDENT. THE REPORTED INCIDENT OCCURRED IN (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10233212 ↗