Cios Fusion 10308192Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04056869009056), received between Dec 24, 2020 and Dec 3, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (1 report).

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.

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.

• MalfunctionDec 3, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  SIEMENS HEALTHINEERS WAS NOTIFIED BY ITS SERVICE ORGANIZATION OF AN ISSUE WITH THE CIOS FUSION SYSTEM. A BLACK SCREEN OCCURRED DURING AN EMERGENCY PROCEDURE, WHICH WAS CONTINUED AND FINISHED USING AN ALTERNATIVE SYSTEM. AS OF THE DATE OF THIS REPORT, THERE ARE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20831172 ↗
• MalfunctionMar 2, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE CIOS FUSION SYSTEM. THE USER REPORTED WHEN MOVING THE C-ARM IT WAS FOUND THAT THE SIDE HANDLE WAS BROKEN. 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 13652664 ↗
• MalfunctionNov 24, 2021Unexpected Shutdown

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE CIOS FUSION SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE DEVICE SUDDENLY AUTOMATICALLY SHUT DOWN AND THEN RESTARTED. FOLLOWING THE RESTART, THE SYSTEM COULD NOT ENTER THE OPERATING 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. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12870036 ↗
• MalfunctionJul 19, 2021Output Problem; Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE CIOS FUSION SYSTEM. THE USER REPORTED THAT THE FOOT SWITCH STOPPED FUNCTIONING DURING A FUNCTION TEST. THE PROCEDURE WAS CONTINUED AND FINISHED USING 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. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188865 ↗
• MalfunctionJun 29, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE CIOS FUSION SYSTEM. THE USER REPORTED THAT THE C-ARM COULDN'T MOVE OR LIFT AND REPORTED AN EXPOSURE FAILURE SPORADICALLY. 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 12083915 ↗
• MalfunctionJan 13, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE CIOS FUSION SYSTEM. THE USER REPORTED THAT AFTER THE PATIENT WAS GIVEN ANESTHESIA, THE SYSTEM DID NOT START UP. 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 11164632 ↗
• MalfunctionDec 24, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHEN USING THE CIOS FUSION SYSTEM. THE CUSTOMER REPORTED THAT THE C-ARM POSITIONING WAS NOT ACCURATE FOR THE PERFORMED PATIENT PROCEDURE. 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 11072037 ↗