SIREMOBIL Compact L 08630506Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04056869008998), received between Sep 5, 2023 and Mar 31, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fire” (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 18, 2026.

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.

• MalfunctionMar 31, 2026Radiation Overexposure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE SIREMOMIL COMPACT L SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE SYSTEM ACTIVATED ON ITS OWN AND POTENTIALLY RELEASED X-RAY. A CONTINUOUS BEEPING SOUND WAS REPORTED AT THE TIME OF THE EVENT. THE UNIT WAS SUBSEQUENTLY RESTARTED, AND THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE WITHOUT FURTHER ISSUES. 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 24742981 ↗
• MalfunctionNov 26, 2025Fire; Fire

  SIEMENS BECAME AWARE OF AN EVENT THAT OCCURRED WHILE OPERATING THE SUREMOBIL COMPACT L SYSTEM. DURING A SURGERY, DENSE BLACK SMOKE WAS OBSERVED EMANATING FROM THE MACHINE, ACCOMPANIED BY A STRONG BURNING SMELL. THE DEVICE WAS IMMEDIATELY REMOVED FROM SERVICE. ON NOVEMBER 11, 2025, SIEMENS WAS INFORMED THAT THE SMOKE CAUSED TEMPORARY DISCOMFORT TO THE PEOPLE PRESENT. DETAILED CLARIFICATIONS OF THIS EVENT ARE CURRENTLY ONGOING; THEREFORE, THE EVENT IS REPORTED IN DOUBT. WE HAVE NO INDICATIONS OF ANY SERIOUS ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PERSONS.

  Patient problems: Insufficient Information

  MAUDE report 23658394 ↗
• MalfunctionJul 7, 2025Smoking; Smoking

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE SIREMOBIL COMPACT L SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, THE USER OBSERVED SMOKE COMING FROM THE MONITOR TROLLEY. THE USER IMMEDIATELY TURNED OFF AND UNPLUGGED THE UNIT. THE PATIENT WAS TRANSFERRED TO A DIFFERENT MEDICAL FACILITY FOR FURTHER 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 22411342 ↗
• MalfunctionSep 5, 2023Radiation Leak; Radiation Output Failure; Radiation Leak; Radiation Output Failure

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE SIREMOBIL COMPACT L (3) SYSTEM. THE FOOTSWITCH WAS STUCK CAUSING THE SYSTEM TO RELEASE RADIATION UNINTENTIONALLY FOR 5 MINUTES. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION TO CONTINUE WITH THE INVESTIGATION. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE PERSONS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682212 ↗