Cios AlphaRecalls & reported problems across all models

We found 2 models of Cios Alpha by Siemens Healthcare GmbH in the FDA's device registry (GUDID). Together they are named in 15 adverse event reports in the FDA's MAUDE database, received between Oct 28, 2020 and Apr 2, 2026 — classified as 1 death, 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Radiation Output Failure” (4 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Cios Alpha recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 12, 2023Open, Classified

   Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure

   Z-0195-2024 · Root cause: Software design · Recall details · FDA record ↗

Most reported Cios Alpha problems

Cios Alpha models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Cios Alpha 11105200

  Interventional fluoroscopic x-ray system
  1 recall1 death6 reports
• Cios Alpha 10308191

  Image-intensified fluoroscopic x-ray system, mobile
  9 reports

Recent Cios Alpha adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJan 2, 2026Insufficient Device Problem Information

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE CIOS ALPHA VA3X SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, THE IMAGE INTENSIFIER MALFUNCTIONED, WHICH LED TO A LONG TERM DELAY. 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 23943480 ↗
• 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 8, 2023Radiation Output Failure; Radiation Output Failure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE CIOS ALPHA VA30 SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, NO X-RAY EXPOSURE WAS AVAILABLE. THE PATIENT HAD TO BE MOVED, AND THE PROCEDURE WAS COMPLETED ON AN ALTERNATE UNIT. 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 18091898 ↗
• DeathOct 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE CIOS ALPHA SYSTEM. THE USER REPORTED THAT DURING AN EMERGENCY INTERVENTIONAL EXAMINATION TYPE ABDOMINAL AORTIC ANEURYSM. THE QUALITY IMAGE OF THE SYSTEM WAS NOT SUITABLE TO PERFORM THE EXAMINATION PROTOCOL ENDOPROSTHESIS. AS A RESULT, THE PHYSICIAN DECIDED TO PERFORM A SURGERY. DURING THE SURGICAL PROCEDURE THAT LASTED 4 HOURS, THE PATIENT PASSED AWAY. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Aneurysm

  MAUDE report 17886165 ↗
• 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 ↗
• InjurySep 13, 2022Electrical /Electronic Property Problem; Unintended Electrical Shock; Electrical /Electronic Property Problem; Unintended Electrical Shock

  IT WAS REPORTED TO SIEMENS THAT AN INCIDENT OCCURRED WITH THE CIOS ALPHA SYSTEM. THE USER RECEIVED AN ELECTRIC SHOCK WHILE REMOVING THE X.10 CONNECTOR. THE OPERATOR COMPLAINED OF PAIN IN HIS FOREARM AND WAS EXAMINED IN THE ER. THE OPERATOR DID NOT SUFFER ANY INJURIES AND WAS FOUND TO BE IN GOOD HEALTH. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT. THE REPORTED EVENT OCCURRED IN SWITZERLAND.

  Patient problems: Electric Shock

  MAUDE report 15412481 ↗
• MalfunctionSep 9, 2022Output Problem; Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE CIOS ALPHA SYSTEM. DURING AN INTERVENTIONAL PROCEDURE WITH A PATIENT IN CRITICAL CONDITION, THE USER REPORTED THAT THE BRAKE ON THE SYSTEM COULD NOT BE RELEASED. THE CLINICAL PROCEDURE HAD TO BE TERMINATED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED THAT THE INVOLVED PATIENT HAD NOT BEEN INJURED. THE REPORTED EVENT IN JAPAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393267 ↗
• 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 ↗
• MalfunctionJan 19, 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 SYSTEM WAS BUSY AND NO FLUORO 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 11192688 ↗
• 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 ↗

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