Luminos dRF Max 10762471Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04056869009155), received between Dec 18, 2020 and Nov 12, 2025 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 reports).

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. Dec 9, 2022Open, Classified

   There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. These devices are not for mammography examinations.

   Z-1002-2023 · Root cause: Process control · FDA record ↗

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.

• MalfunctionNov 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS BECAME AWARE OF AN ISSUE ASSOCIATED WITH THE LUMINOS DRF MAX SYSTEM. AN 11-WEEK-OLD PATIENT WAS UNDERGOING A SWALLOW TEST WHEN SUDDENLY THE COMPRESSION CONE ARM OF THE SYSTEM EXTENDED OUTWARDS. THE CHILD WAS SEATED IN A CAR SEAT-STYLE SEAT WHICH WAS STRAPPED TO THE MAIN SEAT FOR ADULT PATIENTS. THE COMPRESSION ARM HIT THE BACK OF THIS CHAIR WITH A LOUD SOUND, WHICH CAUSED THE CHILD TO ALMOST FALL FORWARDS ONTO THE FLOOR IF THEY WERE NOT CAUGHT BY THEIR PARENT WHO WAS STANDING RIGHT IN FRONT OF THEM. THE ISSUE IS CURRENTLY NOT UNDERSTOOD. IT IS CURRENTLY UNCLEAR WHETHER THERE WAS ANY SYSTEM MALFUNCTION. NO INJURY TO THE PATIENT, STAFF, OR OTHER PEOPLE OCCURRED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23531374 ↗
• MalfunctionMar 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE WITH THE LUMINOS DRF MAX SYSTEM RELATED TO SIEMENS RECALL XP017/24/S, UI XP018/24/S, RES #(B)(4). IT WAS DISCOVERED THAT AT THE FIXATION OF THE MONITOR CEILING SUSPENSION THE SECURING SEGMENT WAS NOT INSTALLED CORRECTLY. THE MONITOR SUPPORT ARM REMAINED ATTACHED TO THE CEILING AND NO INJURY OCCURRED DUE TO THIS ISSUE. IT IS ASSUMED THAT IN A WORST-CASE SCENARIO, IF THE SUPPORT ARM HAD BEEN USED FURTHER WITHOUT NOTICING THE ISSUE, A SERIOUS INJURY COULD BE SUSTAINED FROM FALLING EQUIPMENT. THE ISSUE WAS RESOLVED ON SITE BY THE SERVICE ENGINEER REPLACING AND CORRECTLY INSTALLING THE SECURING SEGMENT AND THE FIXATION SCREWS ACCORDING TO FSCA XP018/24/S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21629410 ↗
• MalfunctionOct 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  SIEMENS HEALTHINEERS BECAME AWARE OF AN ISSUE WITH THE LUMINOS DRF MAX SYSTEM. IT WAS COMMUNICATED TO SIEMENS HEALTHINEERS THAT A CORRUGATED CABLE HOLDER OF THE DISPLAY CEILING STAND FELL. NO ONE WAS IN THE ROOM WHEN THE ASSEMBLY FELL, THEREFORE, NO INJURY OCCURRED. IT IS ASSUMED THAT IN A WORST-CASE SCENARIO, A SERIOUS INJURY COULD RESULT FROM THE FALLING ASSEMBLY IF THE EVENT WERE TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20470978 ↗
• MalfunctionJun 26, 2024Defibrillation/Stimulation Problem; Insufficient Device Problem Information; Defibrillation/Stimulation Problem; Insufficient Device Problem Information

  A SIEMENS HEALTHINEERS CUSTOMER SERVICE ENGINEER (CSE) RECEIVED A MILD ELECTRIC SHOCK WHILE REPLACING A CHARGING RELAY ON THE LUMINOS DRF MAX SYSTEM. THERE WAS NO MODERATE OR SEVERE INJURY ASSOCIATED WITH THIS EVENT. IT IS ASSUMED THAT IN A WORST-CASE SCENARIO, THE CSE MIGHT RECEIVE A POTENTIALLY FATAL ELECTRICAL SHOCK UNDER THE DESCRIBED CIRCUMSTANCES. HISTORICALLY, SIEMENS HEALTHINEERS HAD NO KNOWLEDGE OF THIS TYPE OF ISSUE RESULTING IN A FATAL ELECTRIC SHOCK.

  Patient problems: Electric Shock

  MAUDE report 19613084 ↗
• MalfunctionApr 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  SIEMENS HEALTHINEERS WAS MADE AWARE OF A POTENTIAL PRODUCT PROBLEM INVOLVING THE LUMINOS DFR MAX SYSTEM. WHEN THE USER MOVED THE TUBE STAND, A BUMPER AT THE END OF THE RAIL FELL TO THE FLOOR. THE BUMPER SERVES AS A MECHANICAL END STOP. THERE WAS NO PATIENT INVOLVEMENT AND NO INJURY OCCURRED TO THE USER. IT IS ASSUMED THAT IN A WORST-CASE SCENARIO, A MINOR TO SERIOUS INJURY MAY RESULT IF THE ISSUE TO RECUR AND A PERSON WAS HIT BY THE FALLING PART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19181109 ↗
• InjuryOct 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHCARE WAS MADE AWARE THAT DURING A PROFILE EXAMINATION (LATERAL EXAMINATION), WITH THE TABLE IN THE 90-DEGREE POSITION, THE PATIENT FELL FROM THE FOOT SUPPORT AND BROKE THEIR KNEE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: Bone Fracture(s)

  MAUDE report 18011453 ↗
• MalfunctionSep 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  SIEMENS WAS INFORMED OF AN INCIDENT WITH THE LUMINOS DRF MAX SYSTEM. A PATIENT WAS BROUGHT INTO THE EXAMINATION ROOM IN A WHEELCHAIR. THE PATIENT TABLE WAS IN 90-DEGREE POSITION, WITH THE FOOTREST ATTACHED. THE PATIENT HAD DIFFICULTY GETTING ONTO THE FOOTREST AND HELD ONTO THE HANDGRIP STRIP. DUE TO HIS WEIGHT THE HANDGRIP STRIP DETACHED ON ONE SIDE, AND THE PATIENT FELL. THE PATIENT SUFFERED SOME SKIN ABRASIONS AND BLEEDING, BUT NO BONE FRACTURES. THIS INJURY IS CONSIDERED A MINOR TO MODERATE INJURY. IT IS ASSUMED THAT IN WORST CASE A SERIOUS INJURY MIGHT BE THE OUTCOME SHOULD THE ISSUE RECUR.

  Patient problems: Abrasion

  MAUDE report 17796041 ↗
• MalfunctionJul 20, 2023Material Deformation; Material Deformation

  DURING SERVICE ACTIVITIES IT WAS NOTICED BY THE SIEMENS CUSTOMER SERVICE ENGINEER (CSE) THAT THE HOLES ON THE RAILS INTO WHICH THE FOOT BOARD IS LOCKED ARE WIDER THAN EXPECTED. THE CSE CONFIRMED THAT THE FOOT BOARD CAN BE SAFELY FIXED TO THE PATIENT TABLE CURRENTLY. HOWEVER, IF THE ISSUE WAS NOT NOTICED DURING THE SERVICE ACTIVITIES, IT CANNOT BE EXCLUDED THAT THE HOLES WOULD HAVE EVENTUALLY BECOME MORE WORN OUT OVER TIME, AND THE ATTACHMENT OF THE FOOT BOARD WOULD HAVE BECOME UNSAFE. IN A WORST-CASE SCENARIO, IF THE FOOT BOARD WOULD DETACH FROM THE PATIENT TABLE DURING AN EXAMINATION, A MINOR TO SERIOUS INJURY MIGHT OCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17361558 ↗
• MalfunctionJun 1, 2023Computer Software Problem; Computer Software Problem

  THE ROOM CONFIGURATION PARAMETERS OF THE LUMINOS DRF MAX WERE LOST AND THE PATIENT TABLE DID NOT STOP AT THE INTENDED POSITION DURING TILT MOVEMENT BUT INSTEAD HIT THE CEILING. NO INJURY WAS COMMUNICATED IN THIS CASE. THE ISSUE WAS INITIALLY CLASSIFIED AS NOT REPORTABLE ON (B)(6) 2018, BECAUSE IT WAS DETERMINED THEN THAT ONLY A MODERATE INJURY MIGHT OCCUR. A RETROACTIVE REVIEW OF THE INCIDENT WAS PERFORMED WITH RESPECT TO THE ROOT CAUSE ANALYSIS OF SIEMENS HEALTHCARE CAPA 8DR-XP-QCA-2022-11000378, AND AS A RESULT, THE COMPLAINT WAS RECLASSIFIED TO 3B. THE NEW AWARENESS DATE IS 2023-05-25. IF THE ROOM CONFIGURATION PARAMETERS ARE SET INCORRECTLY OR IF THE ORIGINAL CONFIGURATION IS LOST AND THE DEFAULT VALUES ARE SET, THE SYSTEM MIGHT COLLIDE WITH THE CEILING OR WALLS. IF THE SYSTEM COLLIDES WITH THE CEILING DUE TO A LOST ROOM CONFIGURATION, IN WORST CASE A SERIOUS INJURY MIGHT OCCUR IF A PERSON WERE HIT BY FALLING PARTS. THE ISSUE IS THEREFORE NOW CLASSIFIED AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038022 ↗
• MalfunctionJul 27, 2022Detachment of Device or Device Component

  THE MANUFACTURER WAS INFORMED ABOUT AN INCIDENT THAT OCCURRED ON THE LUMINOS DRF MAX SYSTEM. DURING A PATIENT EXAMINATION THE FOOT BOARD DETACHED FROM THE PATIENT TABLE WHEN THE SYSTEM WAS TILTED ABOUT HALFWAY FROM 0 TO 90 DEGREES. AS A RESULT, THE PATIENT SLID DOWN THE TABLE, LANDING ON HER FEET. THE PATIENT STATED THAT SHE WAS NOT INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15111994 ↗
• MalfunctionJul 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PATIENT EXAMINATION USING THE LUMINOS DRF MAX SYSTEM, THE FOOTREST OF THE PATIENT TABLE CAME OFF WHILE A PATIENT WAS STANDING ON IT. THE PATIENT WAS NOT INJURED. ALTHOUGH NO INJURY OCCURRED IN THIS CASE, IN A WORST-CASE SCENARIO MINOR TO SERIOUS INJURY COULD RESULT IF THE ISSUE REOCCURRED. THE REPORTED EVENT OCCURRED IN THE UNITED KINGDOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15012143 ↗
• MalfunctionJul 7, 2022Unintended Collision; Unintended Collision

  IT WAS REPORTED WHILE TILTING THE LUMINOS DFR MAX SYSTEM TO 90 DEGREES, THE TABLE HIT THE CEILING AND MADE A HOLE IN IT. THERE WAS NO INJURY OR DAMAGE TO THE SYSTEM ASSOCIATED WITH THE EVENT. PROCEDURAL AND PATIENT INFORMATION WAS NOT PROVIDED TO SIEMENS. ON (B)(6) 2022 PICTURES OF THE DAMAGE TO THE CEILING WERE PROVIDED. IT WAS DETERMINED THAT THE HOLE IN THE CEILING WAS LARGER THAN FIRST ASSUMED BASED ON THE INITIALLY SUBMITTED INFORMATION AND, THEREFORE, A RISK OF MODERATE INJURY WAS IDENTIFIED REGARDING PARTS OF THE CEILING THAT MIGHT HAVE FALLEN AND HIT A PERSON IF THIS EVENT WERE TO REOCCUR.. THEREFORE, EVEN THOUGH IN THIS CASE NO INJURIES HAD OCCURRED, WITH THIS NEW AWARENESS IT WAS DECIDED TO REPORT THE ISSUE WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN SPAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14946167 ↗
• MalfunctionJul 1, 2022Unintended Collision; Installation-Related Problem; Unintended Collision; Installation-Related Problem

  THE USER TILTED THE LUMINOS DRF MAX BASIC UNIT FROM -90 DEGREES TO 0 DEGREES AND THEREBY DROVE THE TUBE COLUMN INTO THE CEILING RAIL. DAMAGE TO THE SYSTEM WAS THE RESULT. IT WAS IDENTIFIED THAT THE ROOM CONFIGURATION PARAMETERS WERE SET TO A WRONG VALUE. THIS WRONG ROOM CONFIGURATION LED TO THE COLLISION OF THE SYSTEM WITH THE CEILING RAIL. NO INJURY OR PATIENT INVOLVEMENT WAS COMMUNICATED IN THIS CASE. IN A WORST-CASE SCENARIO, PARTS MIGHT FALL DUE TO THIS ISSUE RESULTING IN SERIOUS INJURY. THIS EVENT IS BEING SUBMITTED WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14884230 ↗
• MalfunctionJun 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO SIEMENS THAT THE PATIENT TABLE HIT THE FLOOR WHILE THE USER WAS MOVING IT INTO THE PATIENT TRANSFER POSITION IN PREPARATION FOR AN UPCOMING EXAMINATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO INJURY WAS SUSTAINED BY THE USER. IT IS ASSUMED THAT IN WORST CASE SCENARIO, SERIOUS CRUSHING INJURY MAY OCCUR IF PATIENT OR OPERATOR GETS CAUGHT BETWEEN THE SYSTEM AND THE FLOOR. THE USER IS RESPONSIBLE FOR ASSURING THAT NO COLLISION TAKES PLACE WHILE MOVING THE SYSTEM. THERE ARE CORRESPONDING NOTES IN THE OPERATOR MANUAL. A SERIOUS INJURY DUE TO THE DESCRIBED ISSUE HAS NOT BEEN REPORTED TO SIEMENS AS OF THE DATE OF THIS REPORT. THIS EVENT HAS BEEN REPORTED WITH AN ABUNDANCE OF CAUTION BECAUSE THE CAUSE OF THE ISSUE HAS NOT BEEN IDENTIFIED YET. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14652433 ↗
• InjuryNov 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED ON THE LUMINOS DRF MAX UNIT. THE OVERHEAD TUBE DROPPED AND HIT THE OPERATOR PRESENT IN THE ROOM. THE TECHNICAL WAS EVALUATED FOR A HEAD INJURY, HOWEVER, NO MEDICAL TREATMENT WAS REQUIRED AND THE TECHNICAL RETURNED TO WORK THE NEXT DAY. THE UNIT WAS RETURNED TO EVERYDAY OPERATION AND NO ISSUES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843599 ↗
• InjuryMay 25, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SIEMENS RECEIVED INFORMATION FROM THE USER THAT DURING A COMMON SWALLOWING EXAMINATION, THE PATIENT WITH AN IMPLANTED PACEMAKER (ICD) SUFFERED A VERY SHORT HEART ARRYTHMIA DISORDER. ACCORDING TO THE USER, THE PATIENT'S PACEMAKER CURVES SHOWED INTERFERENCES DURING THE EXAMINATION. THE PATIENT WAS SITTING DURING THE EXAMINATION. AT THE MOMENT OF THE HEART EPISODE THE PATIENT FELT DIZZY (DISCOMFORT), THEREFORE, THE RADIOLOGIST STOPPED THE PROCEDURE AND ASKED THE PATIENT TO LAY DOWN FOR SEVERAL MINUTES. THE PROCEDURE WAS LATER SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. NO LASTING HEALTH IMPACT WAS COMMUNICATED IN THIS CASE. NO SYSTEM MALFUNCTION COULD BE DETERMINED AT THIS POINT IN TIME. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11876647 ↗
• MalfunctionDec 18, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED TO SIEMENS THAT THE PATIENT TABLE OF THE LUMINOS DRF MAX SYSTEM MOVED AND TILTED WITHOUT GIVEN COMMAND. NO PATIENT INVOLVEMENT OR INJURY WERE COMMUNICATED TO SIEMENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11037775 ↗