Cios Alpha 10308191Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04056869009032), received between Oct 28, 2020 and Apr 2, 2026 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Radiation Overexposure; Radiation Output Problem

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE CIOS ALPHA SYSTEM. WHEN THE UNITS WAS SWITCHED ON DURING PROCEDURE, IT WOULD EITHER TRIGGER X-RAY RELEASE WITHOUT A GIVEN COMMAND FROM THE USER OR FAILED TO STOP THE RELEASE OF RADIATION. 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 24765137 ↗
• MalfunctionNov 5, 2024Computer Operating System Problem; Computer Operating System Problem

  A PATIENT WAS ADMITTED FOR AN ACUTE HEART ATTACK CASE AND SCHEDULED FOR AN ARTERIOGRAM. AN ARTERIOGRAM IS AN IMAGING TEST THAT USES X-RAYS AND A SPECIAL DYE TO VISUALIZE THE INSIDE OF ARTERIES, VEINS, AND HEART CHAMBERS. THIS PROCEDURE IS USED TO LOOK FOR CHANGES IN THE BLOOD VESSELS SUCH AS BLOCKAGES, ETC. DURING THE SCHEDULED ARTERIOGRAM, THE SYSTEM HAD A MALFUNCTION AND COULD NOT RELEASE X-RAY WHICH RESULTED IN THE PATIENT BEING TRANSPORTED TO ANOTHER HOSPITAL TO COMPLETE THE PROCEDURE. NO HEALTH CONSEQUENCES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20608438 ↗
• MalfunctionNov 28, 2022Inappropriate or Unexpected Reset; Reset Problem; Inappropriate or Unexpected Reset; Reset Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE CIOS ALPHA SYSTEM. THE SYSTEM SWITCHED OFF TWICE DURING AN INTERVENTIONAL PATIENT PROCEDURE. HOWEVER, THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED ON THE CONCERNED UNIT. THERE IS NO REPORT OF 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 FRANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870905 ↗
• MalfunctionNov 3, 2021Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE CIOS ALPHA SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE TROLLEY POWERED OFF. 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 12744988 ↗
• MalfunctionOct 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WITH THE CIOS ALPHA SYSTEM. THE USER REPORTED A LEAKAGE OF FLUID FROM THE COOOING SYSTEM WHICH COULD POTENTIALLY LEAK INTO THE PATIENT AREA DURING OPERATION. 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 12655372 ↗
• MalfunctionSep 22, 2021Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE CIOS ALPHA SYSTEM. THE USER REPORTED THAT NO X-RAY WAS POSSIBLE DURING A SURGICAL 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 12511619 ↗
• MalfunctionAug 11, 2021Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE CIOS ALPHA SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE EQUIPMENT SUDDENLY STOPPED WORKING. 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 12306159 ↗
• MalfunctionJul 26, 2021Mechanical Problem; Unintended Movement; Mechanical Problem; Unintended Movement

  IT WAS REPORTED TO SIEMENS THAT A VERTICAL LIFT ON THE CIOS ALPHA SYSTEMS WAS NOT WORKING AND GIVING ERROR 2044/032. ADDITIONAL INFORMATION WAS PROVIDED STATING THAT UNINTENDED MOVEMENT HAD OCCURRED DURING A DIAGNOSTIC PROCEDURE. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION 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 12224866 ↗
• MalfunctionOct 28, 2020No Display/Image; No Display/Image

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE CIOS ALPHA SYSTEM. DURING A PROCEDURE, THE USER REPORTED THAT NO IMAGE WAS DISPLAYED ON THE LIVE MONITOR. 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 10747166 ↗