ARCADIS Orbic 10143407Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04056869009025), received between Dec 16, 2020 and Jun 27, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2024No Display/Image; No Display/Image

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARCADIS ORBIC GEN2 SYSTEM. DURING AN EMERGENCY PROCEDURE, NO IMAGE WAS DISPLAYED ON THE MONITOR WHEN THE USER TRIED TO PERFORM FLUORO. THE USER TRIED TO RE-START THE UNIT, BUT THE SYSTEM REMAINED FROZEN. THE PATIENT WAS RELOCATED TO AN ALTERNATE SYSTEM 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 19623581 ↗
• MalfunctionNov 28, 2022Output Problem; Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARCADIS ORBIC SYSTEM. THE SYSTEM CRASHED THREE TIMES DURING AN INTERVENTIONAL PATIENT PROCEDURE. THE UNIT HAD TO RESTARTED AFTER EACH CRASH PROLONGING THE OPERATION TIME. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT. THE REPORTED EVENT OCCURRED IN CHINA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870823 ↗
• MalfunctionDec 20, 2021Radiation Overexposure; Radiation Overexposure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARCADIS ORBIC GEN 2 SYSTEM. IN THE REGULAR ANNUAL TESTING PERFORMED BY A THIRD PARTY, THE RESULT OF THE X-RAY DOSE RATE EXCEEDS THE LIMITATION. THERE WAS NO PATIENT INVOLVEMENT DURING THIS TESTING. 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 13042749 ↗
• MalfunctionSep 13, 2021Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARCADIS ORBIC GEN 2 SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE C-ARM FAILED SEVERAL TIMES CAUSING A DELAY IN PROCEDURE. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH 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 12459213 ↗
• MalfunctionApr 30, 2021Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARCADIS ORBIC GEN 2 SYSTEM. THE USER REPORTED THAT THE HANDSWITCH BECAME STUCK WHILE TRIGGERING X-RAYS. AT THIS TIME, THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH 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 11752549 ↗
• MalfunctionDec 24, 2020No Display/Image; No Display/Image

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHEN USING THE ARCADIS ORDIC SYSTEM. THERE WAS NO DISPLAY ON THE MONITOR AND THE PATIENT IMAGES COULD NOT BE DISPLAYED. THERE WAS NO REPORT OF ANY ADVERSE EFFECT TO THE HEALTH STATUS OF THE INVOLVED PATIENT. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11071890 ↗
• MalfunctionDec 22, 2020Radiation Output Problem; Radiation Output Problem

  IT WAS REPORTED TO SIEMENS THAT BEFORE A PATIENT PROCEDURE THE FOOTSWITCH WAS MALFUNCTIONING FREQUENTLY. SOMETIMES THE SYSTEM HAD NO REACTION AFTER DEPRESSING THE FOOTSWITCH AND SOMETIME EXPOSURE WAS TRIGGERED AUTOMATICALLY WITHOUT DEPRESSING THE FOOTSWITCH. THERE WAS NO PATIENT INVOLVEMENT. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11060964 ↗
• MalfunctionDec 16, 2020No Display/Image

  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 IMAGING SYSTEM FAILED, RENDERING FLUOROSCOPY UNUSABLE. 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. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11019848 ↗