ARCADIS Varic 10143406Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04056869009018), received between Feb 22, 2021 and Apr 17, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Operating System Becomes Nonfunctional” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2023No Device Output; Radiation Output Problem; No Device Output; Radiation Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARCADIS VARIC GEN 2 MOBILE X-RAY SYSTEM. THE USER REPORTED THAT THEY HAD TO REMOVE THE MAINS POWER CABLE IN ORDER TO STOP FLUOROSCOPY. AS A RESULT, PATIENT TREATMENT WAS TERMINATED. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT OR ANY 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 16750136 ↗
• MalfunctionNov 30, 2022Computer Software Problem; Computer Software Problem

  ON (B)(6) 2022, SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARCADIS VARIS GEN 2 SYSTEM. ON NOVEMBER 16, 2022 INFORMATION WAS RECEIVED THAT THE ISSUE OCCURRED DURING AN EMERGENCY PROCEDURE WHEN THE USER STARTED FLUORO, HOWEVER, SEVERAL SECONDS LATER THE SOFTWARE FROZE. THE USER RESTARTED THE SYSTEM, BUT THE ISSUE RECURRED. THE PROCEDURE WAS COMPLETED ON AN ALTERNATE UNIT. 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 15885624 ↗
• MalfunctionAug 8, 2022Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARCADIS VARIS GEN 2 SYSTEM. DURING SURGERY, THE USER REPORTED THAT NO X-RAY WAS POSSIBLE AND AN ERROR MESSAGE WAS SHOWN. 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 15182193 ↗
• MalfunctionFeb 14, 2022Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARCADIS VARIC GEN 2 SYSTEM. THE USER REPORTED THAT THE INTENSIFIER FAILED DURING AN EXAM WHICH RESULTED IN OVERHEATING DESPITE NORMAL USE. 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 13521854 ↗
• MalfunctionSep 7, 2021Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARCADIS VARIC GEN 2 SYSTEM. DURING A PROCEDURE, THE USER REPORTED THAT X-RAY DID NOT STOP AFTER THE FOOT SWITCH WAS RELEASED. 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 12432346 ↗
• MalfunctionSep 1, 2021Unintended Collision; Unintended Collision

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARCADIS VARIC GEN 2 SYSTEM. DURING A SURGICAL PROCEDURE, THE USER REPORTED THAT THE C-ARM HORIZONTAL COULD NOT BE LOCKED AND THERE WAS A COLLISION WITH THE PATIENT. 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 12406284 ↗
• MalfunctionApr 12, 2021Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARCADIS VARIC GEN 2 SYSTEM. DURING A PROCEDURE, THE USER REPORTED THAT THE DEVICE COULD NOT DISPLAY THE IMAGE. 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 11648074 ↗
• MalfunctionMar 29, 2021Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARCADIS VARIC GEN 2 SYSTEM. DURING OPERATION OF THE SYSTEM, THE USER REPORTED THAT THE SYSTEM HUNG UP. DURING THE ERROR IT APPEARED THAT THE SYSTEM WAS TOTALLY DOWN. 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 11581892 ↗
• MalfunctionFeb 22, 2021Poor Quality Image; Poor Quality Image

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARCADIS VARIC GEN 2 SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT THE SYSTEM DISPLAYED AN ERROR MESSAGE AND THE SYSTEM WAS NO LONGER OPERABLE. 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 11357508 ↗