Mobilett XP 01818363Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04056869009087), received between Dec 22, 2020 and Jul 8, 2024 — classified as 5 malfunctions.

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

4 other recalls cover devices cleared under the same FDA submission (K033238); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2024Unintended Electrical Shock; Unintended Electrical Shock

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE MOBILETT XP SYSTEM. ON JUNE 26, 2024, SIEMENS RECEIVED INFORMATION FROM THE USER THAT THE OPERATORS WERE EXPERIENCING AN ELECTRIC SHOCK LIKE SENSATION WHEN TOUCHING THE SYSTEM HANDLE. NO FURTHER INFORMATION REGARDING THIS EVENT WAS AVAILABLE, AND IT WAS INITIALLY CLASSIFIED AS NOT REPORTABLE. IT WAS ASSUMED THAT THE SENSATION WAS CAUSED BY ELECTROSTATIC DISCHARGE. ON JULY 2, 2024, ADDITIONAL INFORMATION WAS RECEIVED THAT THE GROUND WIRE OF THE MAIN CABLE WAS BROKEN. IT WAS THEN DECIDED TO REPORT THE ISSUE, SINCE A HAZARDOUS SITUATION COULD NOT BE EXCLUDED IN CASE A SECOND FAULT CONDITION WAS PRESENT IN THE SYSTEM. IT WAS CONFIRMED THAT THERE ARE NO INJURIES RELATED TO THIS EVENT.

  Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19687992 ↗
• MalfunctionSep 25, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  SIEMENS BECAME AWARE OF AN ISSUE WITH THE MOBILETT XP UNIT. PER CUSTOMER¿S REQUEST, A LOCAL SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE FACILITY TO CHECK LIGHT FIELD/RADIATION FIELD ACCURACY. DURING THE INSPECTION THE SERVICE ENGINEER NOTICED THAT THREE OF THE FOUR SCREWS OF THE SINGLE TANK FLANGE FIXATIONS WERE NOT TIGHTENED ANYMORE. THE COLLIMATOR WAS DE-INSTALLED, THE SCREWS WERE TIGHTENED, AND THE COLLIMATOR RE-INSTALLED AGAIN. WE HAVE NO INDICATIONS OF ADVERSE EFFECTS ON THE HEALTH STATUS OF PATIENTS, USERS OR THIRD PARTIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807116 ↗
• MalfunctionMar 23, 2022Mechanical Problem; Mechanical Problem

  THE SCREWS HOLDING THE COLLIMATOR COVER ON THE MOBILETT XP UNITS BECAME LOOSE OVER TIME. PERSONNEL AT THE USER'S SITE TOOK THE COVER APART AND REINSTALLED WITHOUT SIEMENS INVOLVEMENT. HOWEVER, THE COLLIMATOR REMAINED UNSTABLE/WOBBLY. THE COLLIMATOR WAS UNABLE TO ROTATE TO 180 DEGREES AS DESIGNED. THE INSPECTION PERFORMED BY SIEMENS SERVICE ENGINEER CONFIRMED THAT THE SCREWS SECURING THE COLLIMATOR TO THE X-RAY TUBE HAD LOOSENED. FOLLOWING CLEANING AND LUBRICATION OF THE ROTATING PARTS, THE COLLIMATOR COULD BE ROTATED NORMALLY AGAIN AND BECAME STEADY FOLLOWING THE REPAIRS. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869973 ↗
• MalfunctionAug 26, 2021Mechanical Problem; Mechanical Problem

  SIEMENS BECAME AWARE OF AN INCIDENT WITH THE MOBILETT XP UNIT. THE OPERATOR WAS MOVING THE UNIT TO THE PATIENT ROOM WHEN HE HEARD A NOISE NEAR THE X-RAY TUBE. WHEN THE OPERATOR TOUCHED THE X-RAY TUBE TO CHECK IT, THE COLLIMATOR FELL DOWN. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370298 ↗
• MalfunctionDec 22, 2020Crack; Unintended Collision

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WITH THE MOBILETT XP DEVICE. DUE TO A VIOLENT IMPACT, THE RIGHT SIDE OF THE SUPPORT ARM HAS SEVERE CRACKS, WHICH MAY CAUSE THE TUBE TO FALL. THE USER WAS ADVISED TO ISOLATE THE UNIT AND STOP ALL USAGE UNTIL REPAIRS ARE COMPLETED. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11059498 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033238. One submission often covers many models, so check the product and lot details in each record.

• Z-1985-2014 · May 9, 2014 · Terminated
  Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and pre
• Z-0171-2011 · Oct 4, 2010 · Terminated
  Mobilett XP and Mobilett XP Hybrid, Mobile radiology device System, x-ray, mobile
• Z-0718-2011 · Oct 4, 2010 · Terminated
  Mobilett XP Hybrid/Digital/CR Intended use: mobile x-ray system
• Z-0749-2007 · Mar 21, 2007 · Terminated
  Mobilett XP, mobile X-ray system, Model number 1818454