Cios Spin 10308194Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04056869153506), received between Jun 24, 2020 and Nov 12, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Problem” (1 report).

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-0196-2024 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2024Output Problem; Output Problem

  SIEMENS HEALTHINEERS WAS NOTIFIED BY ITS SERVICE ORGANIZATION OF AN ISSUE WITH THE CIOS SPIN SYSTEM. DURING AN INTERVENTIONAL PROCEDURE ON (B)(6) 2024, NO X-RAY WAS POSSIBLE, AND THE ISSUE LED TO A DELAY IN THE PROCEDURE. AS OF THE DATE OF THIS REPORT, THERE IS NO INDICATION OF ANY ADVERSE HEALTH EFFECTS TO THE INVOLVED PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662782 ↗
• InjuryDec 28, 2021Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED TO SIEMENS THAT DURING ROUTINE MAINTENANCE WORK ON THE COLLISION DRIVE, THE SIEMENS FIELD SERVICE TECHNICIAN'S PHALANGE WAS JAMMED. THE SERVICE TECHNICIAN WAS PROVIDED WITH FIRST AID TO TREAT THE INJURY. ADDITIONAL EVENT INFORMATION IS PENDING. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13094470 ↗
• MalfunctionJul 20, 2021Unintended System Motion; Unintended System Motion

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE CIOS SPIN SYSTEM. IN PREPARATION FOR THE 3D SCAN, THE C-ARM AUTOMATICALLY MOVED TO THE END POSITION TO START THE TEST RUN. THIS WAS INTERPRETED AS AN UNINTENDED SYSTEM MOVEMENT. 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 12197045 ↗
• MalfunctionJun 24, 2020Use of Device Problem; Radiation Output Failure; Use of Device Problem; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE USING THE CIOS SPIN SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT NO X-RAY WAS POSSIBLE. THE PROCEDURE WAS CONTINUED AND FINISHED 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 Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10190346 ↗