Cios Alpha 11105200Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04056869153490), received between Jan 19, 2021 and Jan 2, 2026 — classified as 1 death, 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗
• 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 ↗