Cios Connect 10308193Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056869009049), received between Nov 7, 2021 and Sep 2, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Operating System Becomes Nonfunctional” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Radiation Output Failure; Radiation Output Failure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE CIOS CONNECT SYSTEM. DURING AN INTERVENTION PATIENT PROCEDURE, NO X-RAY EXPOSURE WAS POSSIBLE. THE PATIENT WAS RELOCATED TO ANOTHER HOSPITAL FOR FURTHER MEDICAL TREATMENT. 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 22938449 ↗
• MalfunctionNov 7, 2021Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE CIOS CONNECT SYSTEM. DURING A PROCEDURE, THE USER REPORTED THAT THE C-ARM STOPPED WORKING. THE FAILURE CAUSED THE OPERATION TO BE SUSPENDED FOR MORE THAN ONE HOUR. 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 12758599 ↗