MOBILETT Elara Max 11107444Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04056869154992), received between Dec 18, 2020 and Sep 4, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2026Insufficient Device Problem Information

  Siemens Healthineers (Siemens) was notified of an event involving an MOBILETT Elara Max system. It was communicated that a member of the hospital staff sustained an electrical shock when they plugged the system in. The person was admitted to the emergency room for examination; however, details regarding the clinical outcome are unknown to Siemens as of the date of this report. This information has been requested by Siemens.

  Patient problems: Electric Shock

  MAUDE report 50609921 ↗
• MalfunctionJun 17, 2024Decoupling; Electrical /Electronic Property Problem; Decoupling; Electrical /Electronic Property Problem

  SIEMENS HEALTHINEERS WAS MADE AWARE OF A POTENTIAL PRODUCT PROBLEM ASSOCIATED WITH A MOBILETT ELARA MAX SYSTEM. THE USER STATED THAT EVERY TIME THE PLUG OF THE MAINS CABLE IS REMOVED FROM THE SOCKET, THE HOUSING OF THE PLUG SLIPS, EXPOSING WIRES AND CONTACTS. THERE WAS NO INJURY ASSOCIATED WITH THIS ISSUE. IT IS ASSUMED THAT IN A WORST-CASE SCENARIO, THE USER MIGHT RECEIVE A POTENTIALLY FATAL ELECTRICAL SHOCK IF THEY TOUCH THE EXPOSED WIRES WHILE THE PLUG IS INSERTED IN THE SOCKET. HISTORICALLY, SIEMENS HEALTHINEERS HAS NOT BEEN MADE AWARE OF ANY FATAL INJURY DUE TO THIS TYPE OF ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19545915 ↗
• MalfunctionNov 16, 2022Activation Failure; Activation Failure

  THE MOBILETT ELARA MAX DID NOT START UP WHEN THE USER WANTED TO USE IT IN AN EMERGENCY CASE. THE SYSTEM DID NOT START UP DUE TO A FAULTY ELECTRONICS CIRCUIT BOARD. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT COMMUNICATED BY THE USER BECAUSE OF THE SYSTEM MALFUNCTION. HOWEVER, THE CUSTOMER'S CONCERN IS THAT IN A WORST-CASE SCENARIO, SERIOUS INJURY OR DEATH COULD OCCUR DUE TO WORKFLOW TIME LOSS IN AN EMERGENCY CASE. BASED ON THE CIRCUMSTANCES DESCRIBED BY THE CUSTOMER, IT IS ASSUMED THAT IN A WORST-CASE SCENARIO THIS MALFUNCTION MIGHT RESULT IN SERIOUS HEALTH IMPACT TO THE PATIENT DUE TO THE DELAY IN DIAGNOSIS AND TREATMENT. THE REPORTED EVENT OCCURRED IN HUNGARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15808044 ↗
• MalfunctionNov 9, 2022Electrical Power Problem; Electrical Power Problem

  THE MOBILETT ELARA MAX SYSTEM POWER PLUG BROKE WITH THE BACK PLATE COMING OFF. AS A RESULT, THE INTERNAL PINS WERE EXPOSED, POSING A RISK OF ELECTRICAL SHOCK IN THE EVENT THEY WERE TOUCHED BY A PERSON WHILE THE PLUG WAS BEING CONNECTED TO THE MAINS. THERE WAS NO PATIENT INVOLVEMENT OR INJURY OF OTHER PERSONS COMMUNICATED TO SIEMENS. THE REPORTED EVENT OCCURRED IN THE UNITED KINGDOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15758361 ↗
• MalfunctionJul 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER OF THE MOBILETT ELARA MAX INFORMED SIEMENS THAT THE COLLIMATOR KNOBS DETACHED FROM THE MACHINE WHILE PREPARING TO TAKE AN EXPOSURE IN A STERILE ENVIRONMENT. THERE IS NO INJURY ATTRIBUTED TO THIS EVENT, HOWEVER, COLLIMATOR KNOBS FALLING INTO A STERILE ENVIRONMENT MAY RESULT IN AN INFECTION TO A PERSON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12134942 ↗
• MalfunctionFeb 12, 2021Loose or Intermittent Connection; Component Missing; Positioning Problem

  SIEMENS BECAME AWARE OF AN ISSUE WITH THE MOBILETT ELARA MAX DEVICE. THE SYSTEM DOES NOT RECOGNIZE THAT THE TUBE ARM IS IN PARKING POSITION DUE TO THE SAFETY SWITCH NOT BEING PROPERLY PRESSED. THE ROD OF THE SAFETY SWITCH FITS INTO A CUTOUT OF THE TUBE ARM HANDLE TO LOCK THE TUBE ARM TO THE SYSTEM WHILE DRIVING OR PARKING THE UNIT. IF THIS SAFETY MECHANISM IS NOT PROPERLY ENGAGED, IT IS NOT POSSIBLE TO DRIVE THE UNIT AT NORMAL SPEED AS THE SYSTEM MOVEMENT IS SET TO SLOW SPEED WHEN THE TUBE ARM IS NOT FASTENED. ADDITIONALLY, AN ISSUE WITH SCREWS ON THE TUBE ARM WAS REPORTED. THE FOUR SCREWS FASTEN THE TUBE ARM TO THE CHASSIS; ON THE CONCERNED UNIT TWO SCREWS WERE MISSING AND TWO SCREWS WERE SLIGHTLY LOOSE. IT WAS DETERMINED BY PRODUCT EXPERTS THAT IN WORST CASE THIS ISSUE COULD CAUSE THE TUBE ARM TO COLLAPSE. A MINOR TO SERIOUS INJURY COULD BE THE OUTCOME IF THE TUBE ARM BECOMES UNSTABLE, MOVES DOWNWARDS UNEXPECTEDLY, AND HITS A PERSON. NO PATIENT INJURY OR MISTREATMENT WAS COMMUNICATED IN THE REPORTED CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11321865 ↗
• MalfunctionDec 18, 2020Break

  IT WAS REPORTED TO SIEMENS THAT DURING SERVICE ACTIVITIES ON THE MOBILETT MIRA MAX SYSTEM, SIEMENS ENGINEER DISCOVERED THAT THE ONE SIDE OF THE COLLIMATOR COVER SAGGED DOWN EVEN THOUGH THE BOLTS WERE TIGHTLY SCREWED. IT WAS DETERMINED THAT ONE OF THE METAL MOUNTING BRACKETS WAS BROKEN DURING THE MANUFACTURING AT THE SPOT WHERE THE BRACKET BENTS. THE ISSUE HAD NOT BEEN NOTICED BY THE USER DUE TO THE COLLIMATOR COVER SITTING TIGHT ON THE FRAME. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11037780 ↗