Mobilett Mira Max 10594738Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04056869009131), received between Aug 18, 2020 and May 6, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 reports).

5 other recalls cover devices cleared under the same FDA submission (K111912); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Key or Button Unresponsive/not Working

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE WITH THE MOBILETT MIRA MAX SYSTEM. IT WAS COMMUNICATED THAT THE EMERGENCY STOP BUTTON WAS BROKEN. ADDITIONAL INFORMATION PROVIDED BY THE SERVICE TECHNICIAN STATED THAT THE REAR CONNECTION WAS BROKEN FROM OVERTURNING THE E-STOP BUTTON AND BREAKING THE PLASTIC THREADING ON THE BUTTON. THIS ISSUE COULD RESULT IN THE EMERGENCY STOP NOT BEING ACTIVATED WHEN PRESSED. ALTHOUGH THERE WAS NO INJURY ASSOCIATED WITH THE COMPLAINT ISSUE, IN A WORST-CASE SCENARIO, NOT BEING ABLE TO ACTIVATE THE EMERGENCY STOP COULD RESULT IN SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093360 ↗
• MalfunctionJan 5, 2026Grounding Malfunction; Electrostatic Discharge

  SIEMENS HEALTHINEERS BECAME AWARE OF AN ISSUE ASSOCIATED WITH THE MOBILETT MIRA MAX SYSTEM. IT WAS STATED THAT WHEN TOUCHING THE SYSTEM HANDLE THE USER RECEIVED AN ELECTROSTATIC DISCHARGE-LIKE SHOCK. THE ISSUE WAS NOTICED WHEN THE SYSTEM WAS PLUGGED INTO MAINS AND SWITCHED ON. THE SERVICE ENGINEER ATTENDING THE SITE PERFORMED LEAKAGE CURRENT TESTS. THESE FAILED AND AN EARTH FAULT WAS IDENTIFIED. THE ISSUE WAS RESOLVED BY REPLACING THE CABLE WINCH. NO INJURY WAS COMMUNICATED IN THIS CASE. THERE WAS NO VISIBLE HARM TO THE USER. IT IS CURRENTLY ASSUMED THAT IN A WORST-CASE SCENARIO THE USER MIGHT RECEIVE AN ELECTRICAL SHOCK IF A SECOND FAULT CONDITION WOULD BE PRESENT AT THE SYSTEM AND THE GROUND WIRE WERE NOT ATTACHED CORRECTLY. ACCORDING TO OUR KNOWLEDGE, A SERIOUS INJURY OR DEATH DUE TO SUCH AN ISSUE HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956596 ↗
• MalfunctionJul 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  SIEMENS BECAME AWARE OF AN ISSUE WITH THE COLLIMATOR ON THE MOBILETT MIRA MAX SYSTEM. THE COLLIMATOR BECAME LOOSE AS ONE OF THE TWO MOUNTING BRACKETS BROKE. HOWEVER, THE COLLIMATOR DID NOT FALL OFF. SIEMENS IS NOT AWARE OF ANY INJURIES RELATED TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19837480 ↗
• MalfunctionJul 16, 2024Electrical Power Problem; Electrical Power Problem

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE WITH THE MOBILETT MIRA MAX SYSTEM. IT WAS COMMUNICATED THAT THE POWER CABLE WAS SPLIT, AND WIRES WERE EXPOSED NEAR THE MAINS PLUG. SPARKS WERE CREATED WHEN ATTEMPTING TO CHARGE THE SYSTEM. NO INJURY OCCURRED DUE TO THIS EVENT. IT IS ASSUMED THAT IN A WORST-CASE SCENARIO, THE USER MIGHT RECEIVE AN ELECTRICAL SHOCK IF THEY WERE TO TOUCH THE EXPOSED WIRES WHILE THE PLUG IS INSERTED IN THE SOCKET, RESULTING IN DEATH. AS OF THE DATE OF THIS REPORT, SIEMENS HEALTHINEERS IS UNAWARE OF SERIOUS INJURY OF DEATH HAVING RESULTED DUE TO THIS TYPE OF ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19749721 ↗
• InjuryNov 16, 2023Failure to Advance; Failure to Advance

  SIEMENS HEALTHCARE WAS MADE AWARE OF AN INJURY THAT OCCURRED DURING TRANSPORTATION OF THE MOBILETT MIRA MAX SYSTEM. WHEN THE OPERATOR WAS ROLLING THE SYSTEM DOWN THE USER FACILITY HALLWAY IT STOPPED ABRUPTLY. THIS CAUSED THE OPERATOR TO JAM THEIR RIGHT HAND INTO THE DRIVE HANDLE. AS A RESULT, THE OPERATOR´S RIGHT THUMB WAS FRACTURED. SINCE THE THUMB FULFILLS AN IMPORTANT FUNCTION IN GRIPPING (IT IS USED FOR THE PINCH GRIP), A FRACTURED THUMB IS CLASSIFIED AS A SERIOUS INJURY AND THE INCIDENT IS THEREFORE CLASSIFIED AS REPORTABLE.

  Patient problems: Bone Fracture(s); Hyperextension

  MAUDE report 18156334 ↗
• MalfunctionSep 19, 2023Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  THE COLLIMATOR DETACHED FROM THE MOBILETT MIRA MAX SYSTEM AND FELL. EVEN THOUGH NO INJURY WAS COMMUNICATED IN THIS CASE, IT IS ASSUMED THAT IN WORST CASE SCENARIO A MINOR TO SERIOUS INJURY MIGHT BE THE OUTCOME IF A PERSON WERE HIT BY A FALLING COLLIMATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772975 ↗
• MalfunctionJul 19, 2023Electrical Shorting; Electrical Shorting

  ADDITIONAL INFORMATION. IT WAS ADDITIONALLY STATED BY THE CUSTOMERS THAT WHEN THE SYSTEM WAS PLUGGED IN FOR CHARGING, SPARKS, SOME SMOKE, AND FIRE WERE NOTICED.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 17351211 ↗
• MalfunctionJun 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE COMPLAINT DESCRIBES THAT FOUR (4) SCREWS HOLDING THE TUBE COVER OF THE MOBILETT MIRA MAX SYSTEM WERE MISSING AND NEEDED TO BE REPLACED. IT IS STATED IN THE OPERATOR MANUAL TO PERFORM A DAILY CHECK OF THE SYSTEM. DURING THE DAILY CHECK LOOSE PARTS SHOULD BE NOTICED. CURRENTLY IT IS NOT CLEAR WHICH EXACT SCREWS WERE MISSING AND WHICH TUBE COVER WAS ASSOCIATED WITH THEM. SINCE IT WAS STATED THAT THE SCREWS OF THE TUBE COVER WERE MISSING, IT IS ASSUMED THAT IN WORST CASE SCENARIO, A MINOR TO SERIOUS INJURY MIGHT BE THE OUTCOME IF A PERSON WERE HIT BY THE FALLING PART. NO INJURY OR FALLING PARTS WERE COMMUNICATED IN THIS CASE. POTENTIAL PATIENT INFORMATION WAS NOT AVAILABLE. THE ISSUE IS BEING REPORTED WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN THE UNITED KINGDOM.

  Patient problems: Insufficient Information

  MAUDE report 14851672 ↗
• MalfunctionFeb 2, 2022Display or Visual Feedback Problem; Output Problem; Display or Visual Feedback Problem; Output Problem

  SIEMENS BECAME AWARE OF AN INCIDENT WITH THE MOBILETT MIRA MAX MOBILE X-RAY UNIT. A NEWBORN IN FRAGILE STATE OF HEALTH WAS BEING IMAGED ON THE DEVICE. AFTER THE FIRST IMAGE WAS TAKEN AND A LATERAL IMAGE WAS ABOUT TO BE PERFORMED, THE SYSTEM DISPLAYED AN ERROR MESSAGE; THE EXAMINATION COULD NOT BE COMPLETED ON THE CONCERNED UNIT. HOWEVER, IT WAS NOT NECESSARY TO USE A BACKUP SYSTEM AS THE USER WAS ABLE TO MAKE DIAGNOSIS USING THE FIRST IMAGE. NO LASTING IMPAIRMENT OF THE NEWBORN WAS COMMUNICATED; HOWEVER, THE USER WAS CONCERNED ABOUT DELAY OF THE PROCEDURE. THE REPORTED INCIDENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13422666 ↗
• MalfunctionJul 7, 2021Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  SIEMENS LOCAL SERVICE REPORTED THAT ALLEN HEAD SCREWS ON THE TUBE FORK OF THE MOBILETT MIRA MAX WERE FOUND TO BE BROKEN. IN WORST CASE, IF THE TUBE FORK BECOMES DETACHED, A PERSON MAY BE HIT BY THE FALLING TUBE, RESULTING IN A MINOR TO A SERIOUS INJURY. NO INJURY OR PATIENT INVOLVEMENT WAS COMMUNICATED IN THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127711 ↗
• MalfunctionMar 23, 2021Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT A COVER BRACKET OF THE MOBILETT MIRA MAX BROKE OFF CAUSING THE SCREWS ATTACHED TO THE BRACKET TO BE FREE FLOAT. THE ISSUE WAS NOTICED BY SERVICE PERSONNEL WHILE REPLACING SCREWS ON THE SYSTEM. THE COLLIMATOR ASSEMBLY WAS REPLACED ON THE CONCERNED UNIT. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11553496 ↗
• MalfunctionJan 29, 2021Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT ONE OF TWO COLLIMATOR COVER BRACKETS OF THE MOBILETT MIRA MAX SNAPPED OFF. THE STRUCTURE OF THE UNIT REMAINED INTACT; ONLY SLIGHT WOBBLING WAS VISIBLE. NO RISK OF FALLING PARTS WAS REPORTED. HOWEVER, THE ENTIRE COLLIMATOR TO AVOID ANY POTENTIAL RISKS. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11252578 ↗
• MalfunctionDec 22, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  SIEMENS WAS INFORMED ABOUT A POTENTIAL RISK WITH THE MOBILETT MIRA MAX SYSTEM. THE COLLIMATOR BECAME LOOSE AND ACCORDING TO THE USER APPEARED TO BE ABOUT TO FALL OFF THERE ARE NO INJURIES ARE ATTRIBUTED TO THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11059528 ↗
• MalfunctionDec 16, 2020Break; Material Integrity Problem; Break; Material Integrity Problem

  SIEMENS WAS INFORMED ABOUT POTENTIAL RISK WITH THE MOBILETT MIRA MAX SYSTEM. SIEMENS LOCAL SERVICE REPORTED THAT DURING SERVICE ACTIVITIES IT WAS DISCOVERED THAT A COLLIMATOR COVER MOUNT WAS BROKEN ON ONE SIDE UNDER THE COVER. NO INJURIES ARE ATTRIBUTED TO THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11019864 ↗
• MalfunctionDec 16, 2020Break; Material Integrity Problem; Break; Material Integrity Problem

  SIEMENS WAS INFORMED ABOUT POTENTIAL RISK WITH THE MOBILETT MIRA MAX SYSTEM. SIEMENS LOCAL SERVICE REPORTED THAT DURING SERVICE ACTIVITIES IT WAS DISCOVERED THAT A COLLIMATOR COVER MOUNT WAS BROKEN ON ONE SIDE UNDER THE COVER. NO INJURIES ARE ATTRIBUTED TO THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11019850 ↗
• MalfunctionDec 11, 2020No Display/Image; No Device Output; Output Problem; No Display/Image; No Device Output; Output Problem

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED ON THE MOBILETT MIRA MAX. THORAX ACQUISITION COULD NOT BE PERFORMED ON A NEWBORN PATIENT IN THE INTENSIVE CARE UNIT. THE PATIENT WAS IN CRITICAL CONDITION WHEN THE MALFUNCTION OCCURRED. A LIFESAVING PROCEDURE WAS INITIATED BY MEDICAL PERSONNEL. NO FURTHER IMPAIRMENTS OR INJURIES HAVE BEEN COMMUNICATED TO SIEMENS. THE REPORTED INCIDENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10992747 ↗
• MalfunctionAug 18, 2020Use of Device Problem; Use of Device Problem

  SIEMENS WAS INFORMED ABOUT POTENTIAL RISK WITH THE MOBILETT MIRA MAX SYSTEM. THE METAL MOUNTING PLATE OF THE COLLIMATOR BROKE AT THE BENDING PART OF THE HANDLE, WHEN THE COLLIMATOR WAS USED TO POSITION THE TUBE OVER THE PATIENT. THE COLLIMATOR COVER WAS DANGLING; HOWEVER, NO FALLING PARTS WERE COMMUNICATED. NO INJURIES ARE ATTRIBUTED TO THIS CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10420233 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111912. One submission often covers many models, so check the product and lot details in each record.

• Z-0223-2024 · Oct 5, 2023 · Open, Classified
  Mobilett Mira wireless (VA20) mobile x-ray system(s)
• Z-1875-2013 · May 2, 2013 · Terminated
  Mobiletta Mira Mobile X-ray System
• Z-0480-2013 · Oct 10, 2012 · Terminated
  Siemens Mobilette Mira, intended use as Mobile x-ray system.
• Z-2322-2012 · Aug 21, 2012 · Terminated
  Siemens Mobilett Mira. Mobile X-Ray System.
• Z-2367-2012 · Apr 30, 2012 · Terminated
  Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system