Luminos Agile Max 10762472Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 04056869009162), received between Dec 18, 2020 and Sep 28, 2026 — classified as 1 injury, 36 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 reports).

3 FDA recall records name this device's identifier, 3 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. Jul 2, 2024Open, Classified

   The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays

   Z-2525-2024 · Root cause: Under Investigation by firm · FDA record ↗

2. Dec 21, 2022Open, Classified

   Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

   Z-1167-2023 · Root cause: Software design · FDA record ↗

3. 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Activation Failure

  Siemens Healthineers was notified of a malfunction involving a Luminos Agile Max system. According to the Siemens service engineer, the system's emergency stop button was found to be broken and nonfunctional. No patient injury, user injury, or adverse event was reported in connection with this malfunction.Although no injury occurred in this event, the inability to actuate the emergency stop button could, in a worst-case scenario, delay or prevent the interruption of system motion during an emergency. If no alternative emergency stop buttons were activated, a serious injury to a patient or operator could potentially occur.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916381 ↗
• MalfunctionMay 7, 2026Improper or Incorrect Procedure or Method

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A SERVICE ISSUE WITH THE LUMINOS AGILE MAX SYSTEM. IT WAS COMMUNICATED BY THE SERVICE TECHNICIAN THAT WHILE HE WAS PERFORMING A SPRING PULLEY REPLACEMENT ON THE SYSTEM, THE TELESCOPE STAND MOVED VERY QUICKLY AND BROKE THE TABLE SUPPORT. THIS TYPE OF EVENT MAY OCCUR IF THE SERVICE TECHNICIAN DOES NOT LOCK THE SAFETY LOCK OF THE SPRING PULLEY BEFORE REPLACING THE SPRING PULLEY, AS INDICATED IN THE SERVICE DOCUMENTATION. DURING THIS EVENT, THE OVERHEAD COLUMN CAN MOVE UPWARDS WITH HIGH SPEED AND FORCE AS SOON AS THE LAST SCREW IS DETACHED FROM THE TUBE ASSEMBLY. ALTHOUGH THERE WAS NO INJURY ASSOCIATED WITH THE COMPLAINT ISSUE AND THE EVENT OCCURRED DURING SERVICE WITH NO PATIENT OR USER INVOLVEMENT, IN A WORST-CASE SCENARIO, SERIOUS INJURY COULD OCCUR IF A SERVICE TECHNICIAN WAS IN THE PATH OF THE STAND WHEN IT MOVED QUICKLY WITH HIGH FORCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110925 ↗
• MalfunctionJun 17, 2025Break; Break

  SIEMENS HEALTHINEERS BECAME AWARE OF AN ISSUE WITH THE LUMINOS AGILE MAX SYSTEM. THE CUSTOMER COMMUNICATED THAT A PATIENT FELL WHEN A PIECE OF THE FOOTBOARD BROKE OFF. THERE WERE NO INJURIES RESULTING FROM THE EVENT. IT IS ASSUMED THAT, IN A WORST-CASE SCENARIO, A SERIOUS INJURY MIGHT HAVE RESULTED FROM A PERSON FALLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22245956 ↗
• MalfunctionApr 2, 2025Component Misassembled; Component Misassembled

  SIEMENS HEALTHINEERS DISCOVERED WITHIN THE SCOPE OF FIELD SAFETY CORRECTIVE ACTION (FSCA) XP018/24/S (RES # 94948) THAT THE SECURING SEGMENT OF THE FIXATION FOR THE MONITOR CEILING SUSPENSION WAS NOT INSTALLED CORRECTLY BEFORE PERFORMING THE CORRECTIVE ACTION. THE ISSUE WAS RESOLVED ON-SITE BY THE SIEMENS SERVICE ENGINEER REPLACING AND CORRECTLY INSTALLING THE SECURING SEGMENT AND THE FIXATION SCREWS ACCORDING TO XP018/24/S. NO INJURY OCCURRED DUE TO THE REPORTED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751340 ↗
• MalfunctionMar 24, 2025Component Misassembled; Component Misassembled

  SIEMENS HEALTHINEERS DISCOVERED DURING FIELD SAFETY CORRECTIVE ACTION (FSCA) XP018/24/S (RES# 94948) THAT THE SECURING SEGMENT OF THE FIXATION FOR THE MONITOR CEILING SUSPENSION WAS INSERTED INVERSELY BEFORE PERFORMING THE UPDATE. THE ISSUE WAS RESOLVED ON-SITE BY THE SIEMENS SERVICE ENGINEER REPLACING AND CORRECTLY INSTALLING THE SECURING SEGMENT AND THE FIXATION SCREWS ACCORDING TO XP018/24/S. NO INJURY OCCURRED DUE TO THE REPORTED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678883 ↗
• MalfunctionMar 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE WITH THE LUMINOS AGILE MAX SYSTEM RELATED TO SIEMENS RECALL XP017/24/S UI XP018/24/S, RES #94948. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503082 ↗
• MalfunctionFeb 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE WITH THE LUMINOS AGILE MAX SYSTEM RELATED TO SIEMENS RECALL 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372863 ↗
• MalfunctionJan 24, 2025Fracture; Fracture

  DURING PREVENTATIVE MAINTENANCE, THE SERVICE ENGINEER DISCOVERED A CRACK IN A COVER OF THE DISPLAY CEILING SUSPENSION (DCS). IT WAS UNCLEAR HOW THE DAMAGE HAD HAPPENED. IT IS ASSUMED THAT THE USER TILTED THE SYSTEM OR COLLIDED ANOTHER OBJECT ONTO THE DCS ARM BY ACCIDENT. IN A WORST-CASE SCENARIO, PERSONS COULD BE SERIOUSLY INJURED BY FALLING PARTS DUE TO A COLLISION OF THE SYSTEM OR OTHER OBJECT WITH THE DCS. NO INJURY WAS COMMUNICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228602 ↗
• MalfunctionDec 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE WITH THE LUMINOS AGILE MAX SYSTEM RELATED TO SIEMENS RECALL XP017/24/S, RES #:(B)(4). DURING SERVICE FOR THIS RECALL THE SIEMENS CUSTOMER SERVICE ENGINEER DISCOVERED THAT THE SECURING SEGMENT WAS INSERTED THE WRONG WAY AROUND AND WAS STICKING OUT. ALSO, THE COUNTERSUNK SCREW WAS NOT SCREWED CORRECTLY. THE CYLINDER SCREW LOOKS CORRECTLY FIXED. THE ISSUE WAS RESOLVED ON SITE BY THE SERVICE ENGINEER REPLACING AND CORRECTLY INSTALLING THE SECURING SEGMENT AND THE FIXATION SCREWS ACCORDING TO RESOLUTION UPDATE XP018/24/S. THE CUSTOMER HAD NOT BEEN AWARE OF THE ISSUE. THE MONITOR SUPPORT ARM REMAINED ATTACHED TO THE CEILING AND NO INJURY OCCURRED IN THIS CASE. IT IS ASSUMED THAT IN A WORST-CASE SCENARIO, IF THE SUPPORT ARM HAD BEEN USED FURTHER WITHOUT NOTICING THE ISSUE, IT MIGHT HAVE LED TO A SERIOUS INJURY BY LARGE PARTS FALLING DOWN AND HITTING A PERSON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20923296 ↗
• MalfunctionSep 3, 2024Unintended Movement; Unintended Movement

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE LUMINOS AGILE MAX SYSTEM. BASED ON THE PROVIDED INFORMATION, IT IS UNDERSTOOD THAT THE UNIT WOULD START TO TILT WHEN ANY BUTTON ON THE OPTIGRIP OR TABLE SIDE CONTROL WAS PRESSED. WITH THE CURRENTLY AVAILABLE INFORMATION, IT IS ASSUMED THAT MOVEMENT STOPS WHEN THE USER LETS GO OF THE BUTTON. NO INJURY WAS COMMUNICATED IN THIS CASE. IT IS ASSUMED THAT IN WORST CASE A MINOR TO SERIOUS INJURY MIGHT BE THE OUTCOME IF THE SYSTEM MOVES UNEXPECTEDLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125367 ↗
• MalfunctionAug 23, 2024Component Missing; Insufficient Device Problem Information; Component Missing; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE WITH THE LUMINOS AGILE MAX SYSTEM. IT WAS COMMUNICATED THAT THE MOUNTING SCREW IN THE TUBE ATTACHMENT OF THE DISPLAY CEILING SUSPENSION WAS MISSING, AND THE SUPPORT ARM HAD LOWERED A BIT, BUT DID NOT FALL DOWN COMPLETELY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048320 ↗
• MalfunctionAug 22, 2024Mechanical Problem; Unintended Collision; Mechanical Problem; Unintended Collision

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE LUMINOS AGILE MAX SYSTEM. WHILE TILTING THE PATIENT TABLE TO THE VERTICAL POSITION, THE OPERATOR RAN THE TABLE INTO THE DISPLAY CEILING SUSPENSION (DCS) CAUSING A COVER ON AN ARM JOINT TO BREAK AND FALL OFF. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20027979 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS BECAME AWARE OF ISSUES ON-SITE WITH THE INSTALLATION OF THE DISPLAY CEILING SUSPENSION ON THE LUMINOS AGILE MAX SYSTEM. NO FURTHER INFORMATION ABOUT THE REPORTED HAS BEEN PROVIDED. THERE ARE NO INJURIES RELATED TO THIS EVENT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19838628 ↗
• MalfunctionJul 24, 2024Component Missing; Component Missing

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE WITH THE LUMINOS AGILE MAX SYSTEM. IT WAS COMMUNICATED THAT THE CUSTOMER VISUALLY INSPECTED THE MOUNTING OF THE SUPPORT ARM OF THE CEILING SUSPENSION PER SIEMENS HEALTHINEERS CUSTOMER SAFETY ADVISORY NOTIFICATION XP017/24/S. THE CUSTOMER IDENTIFIED THAT THE MOUNTING SCREW IN THE SUPPORT ARM OF THE DISPLAY CEILING SUSPENSION WAS MISSING. 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, A SERIOUS INJURY COULD RESULT IF A PERSON WAS LOCATED BENEATH THE DISPLAY MONITOR DURING ADJUSTMENT, AND IT SUDDENLY LOWERED. INJURY COULD BE SUSTAINED FROM THE FALLING EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19816473 ↗
• MalfunctionJul 23, 2024Installation-Related Problem; Installation-Related Problem

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE WITH THE LUMINOS AGILE MAX SYSTEM. IT WAS COMMUNICATED THAT THE CUSTOMER VISUALLY INSPECTED THE MOUNTING SCREW ON THE SUPPORT ARM OF THE CEILING SUSPENSION PER SIEMENS HEALTHINEERS CUSTOMER SAFETY ADVISORY NOTIFICATION XP017/24/S. THE CUSTOMER STATED THAT THERE IS AN ISSUE WITH THE ON-SITE INSTALLATION OF THE DISPLAY CEILING SUSPENSION. ADDITIONAL INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. NO INJURY OCCURRED BECAUSE OF THE ISSUE. IT IS ASSUMED THAT IN A WORST-CASE SCENARIO, IF THE SUPPORT ARM HAD BEEN USED FURTHER WITHOUT NOTICING THE ISSUE, IT MIGHT HAVE LED TO A SERIOUS INJURY BY LARGE PARTS FALLING DOWN AND HITTING A PERSON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804357 ↗
• MalfunctionJul 23, 2024Component Missing; Component Missing

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE WITH THE LUMINOS AGILE MAX SYSTEM. THE SIEMENS CUSTOMER SERVICE ENGINEER WAS ON-SITE AND IDENTIFIED THAT THE ALLEN (MOUNTING) SCREW IN THE TUBE ATTACHMENT OF DISPLAY CEILING SUSPENSION WAS MISSING. THE MONITOR SUPPORT ARM REMAINED ATTACHED TO THE CEILING AND NO INJURY OCCURRED IN THIS CASE. IT IS ASSUMED THAT IN A WORST-CASE SCENARIO, IF THE SUPPORT ARM HAD BEEN USED FURTHER WITHOUT NOTICING THE ISSUE, IT MIGHT HAVE LED TO A SERIOUS INJURY BY LARGE PARTS FALLING DOWN AND HITTING A PERSON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804066 ↗
• MalfunctionMay 22, 2024Disconnection; Component Missing; Disconnection; Component Missing

  ADDITIONAL INFORMATION: SIEMENS HEALTHINEERS RECEIVED ADDITIONAL INFORMATION REGARDING AN INSTALLATION PROBLEM AT THE CUSTOMER SITE. ON 2024-06-14, THE SIEMENS CUSTOMER SERVICE ENGINEER (CSE) VISITED THE CUSTOMER SITE TO INSTALL THE MISSING CYLINDER SCREW, HE NOTICED THAT THE GROUNDING WIRE FOR THE BOOM ARM TROLLEY WAS NOT ATTACHED. THE RISKS ASSOCIATED WITH THIS ISSUE WERE EVALUATED ON 2024-06-20. NO INJURIES OCCURRED AT THE CUSTOMER SITE DUE TO THIS SECOND INSTALLATION ISSUE. IT IS ASSUMED THAT IN A WORST-CASE SCENARIO, IF THERE HAD BEEN AN ELECTRICAL FAULT WITHIN THE DCS, THE UNCONNECTED GROUNDING WIRE MIGHT HAVE LED TO A POTENTIALLY FATAL ELECTRICAL SHOCK. CURRENTLY, SIEMENS HEALTHINEERS HAS NOT BEEN MADE AWARE OF ANY INJURY ASSOCIATED WITH AN UNCONNECTED GROUND WIRE IN THE DISPLAY CEILING STAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19369726 ↗
• MalfunctionMar 28, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  SIEMENS HEALTHINEERS BECAME AWARE OF A POTENTIAL PRODUCT PROBLEM INVOLVING THE LUMINOS AGILE MAX SYSTEM. DURING SERVICE ACTIVITIES THE SIEMENS HEALTHINEERS SERVICE ENGINEER NOTICED THAT THE SHAFT THAT CONNECTS THE MONITOR SUPPORT ARM (DISPLAY CEILING STAND) TO THE CARRIAGE HAD SLID DOWN SEVERAL CENTIMETERS. THE MONITOR SUPPORT ARM REMAINED ATTACHED TO THE CEILING. THERE WAS NO INJURY ASSOCIATED WITH THIS ISSUE. IT IS ASSUMED THAT IN A WORST-CASE SCENARIO, IF THE SUPPORT ARM USE HAD CONTINUED WITHOUT NOTICING THE ISSUE, IT MIGHT HAVE LED TO A SERIOUS INJURY DUE TO LARGE PARTS FALLING AND HITTING A PERSON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18993737 ↗
• MalfunctionMar 18, 2024Unintended Movement; Unintended Movement

  SIEMENS HEALTHINEERS BECAME AWARE OF A POTENTIAL PRODUCT MALFUNCTION AFTER ANALYSIS OF THE LUMINOS AGILE MAX SYSTEM LOG FILES. THE PROVIDED LOG FILES SHOWED A TOGGLING PATTERN OF BLOCKED MOVEMENT BUTTONS AND ERROR 509/017 HAD OCCURRED SEVERAL TIMES SINCE (B)(6) 2024. IT WAS UNCLEAR IF THERE WAS ANY UNINTENDED MOVEMENT DURING CLINICAL WORKFLOW DURING THIS TIME. INFORMATION WAS RECEIVED ON MARCH 11, 2024, STATING THERE WAS UNINTENDED MOVEMENT STARTING IN THE BEGINNING OF (B)(6) 2024. THE PATIENT TABLE WOULD MOVE ONLY BY THE USER TOUCHING THE JOYSTICK/OPTIGRIP WITHOUT ACTIVATING A MOVEMENT BUTTON. THE UNINTENDED MOVEMENT WOULD HAVE STOPPED AS SOON AS THE USER LET GO OF THE OPTIGRIP. THE USER CAN ALWAYS STOP UNINTENDED MOVEMENT BY PRESSING AN EMERGENCY STOP BUTTON. IT IS ASSUMED THAT THIS UNEXPECTED MOVEMENT COULD LEAD TO A SERIOUS INJURY IN A WORST-CASE SCENARIO. THE ISSUE IS THEREFORE NOW CLASSIFIED AS REPORTABLE WITH THE NEW AWARENESS OF MARCH 11, 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18920293 ↗
• MalfunctionFeb 27, 2024Unintended System Motion; Mechanical Jam; Unintended System Motion; Mechanical Jam

  SIEMENS HEALTHINEERS WAS INFORMED OF A POTENTIAL PRODUCT MALFUNCTION ISSUE WHEN USING THE LUMINOS AGILE MAX SYSTEM DURING AN EXAMINATION. IT WAS STATED THAT WHEN THE BOTTOM EDGE OF A TABLE TILT BUTTON WAS PRESSED, THE BUTTON STUCK ON THE CONTROL HANDLE (OPTIGRIP). THE USER WAS ABLE TO STOP THE MOVEMENT BEFORE THE TABLE TILTED TOO FAR. MOVEMENT STOPS WHEN THE USER LETS GO OF THE OPTIGRIP. THE USER CAN ALSO STOP SYSTEM MOVEMENT BY PRESSING AN EMERGENCY STOP BUTTON. NO INJURY TO THE PATIENT OR USER WAS COMMUNICATED FOR THIS EVENT. HOWEVER, IT IS ASSUMED THAT IN WORST CASE SCENARIO, A MINOR TO SERIOUS INJURY MIGHT BE THE OUTCOME SHOULD THE ISSUE RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18787215 ↗
• MalfunctionFeb 7, 2024Unintended Movement; Unintended Movement

  SIEMENS HEALTHINEERS WAS INFORMED OF A POTENTIAL PRODUCT MALFUNCTION ISSUE WHEN USING THE LUMINOS AGILE MAX SYSTEM. IT WAS STATED THAT WHEN THE OPTIGRIP (CONTROL ELEMENT) WAS TOUCHED, THE SYSTEM STARTED TO TILT EVEN THOUGH NO MOVEMENT BUTTON WAS ACTIVATED BY THE USER. BASED ON THE CURRENTLY AVAILABLE INFORMATION, IT IS ASSUMED THAT MOVEMENT WOULD HAVE STOPPED WHEN THE USER LET GO OF THE OPTIGRIP. NO INJURY WAS COMMUNICATED FOR THIS EVENT. HOWEVER, IN A WORST-CASE SCENARIO, A MINOR TO SERIOUS INJURY MAY RESULT IF THE SYSTEM MOVES UNEXPECTEDLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658663 ↗
• MalfunctionOct 24, 2023Activation Problem; Activation Problem

  THE EMERGENCY STOP BUTTON (SWITCH) ON THE LUMINOS AGILE MAX SYSTEM WAS FOUND TO BE BROKEN AND NO LONGER FUNCTIONAL. THERE WERE NO INJURIES COMMUNICATED FOR THIS EVENT. IN A WORST-CASE SCENARIO, IF THE OPERATOR WERE TO CONTINUE TO USE THE SYSTEM WITH THE DEFECTIVE EMERGENCY STOP SWITCH, A COLLISION MIGHT NOT BE PREVENTED IN AN EMERGENCY IF THE USER DOES NOT PRESS AN ALTERNATIVE EMERGENCY STOP BUTTON. THIS ISSUE COULD RESULT IN A SERIOUS INJURY. IN CASE OF FAILURE OF THE EMERGENCY STOP AT THE TABLETOP, THE USER CAN STOP ANY MOVEMENT IMMEDIATELY WITH ADDITIONAL EMERGENCY STOP BUTTONS LOCATED ON THE BUCKY WALL STAND (IF AVAILABLE) AND ON THE CONTROL ROOM MODULE / REMOTE CONTROL CONSOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994317 ↗
• MalfunctionSep 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PATIENT EXAMINATION THE FOOTREST FELL OFF THE TABLE. THE USER HAD PLACED A 12-MONTH-OLD BABY STRAPPED INTO A CHAIR ONTO THE FOOTREST. THE TABLE WAS TILTED TO 90 DEGREES. WHEN THE FOOTREST DETACHED FROM THE TABLE, THE CHAIR FELL WITH IT. NEITHER THE BABY NOR OTHERS WERE INJURED. IT IS ASSUMED THAT IN WORST CASE SCENARIO, THE ISSUE MIGHT LEAD TO A MINOR TO SERIOUS INJURY IF THE ISSUE SHOULD RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17773040 ↗
• MalfunctionJul 27, 2023Break; Break

  THE EMERGENCY STOP BUTTON BROKE OFF THE TABLE WHEN A PATIENT BED COLLIDED WITH THE TABLE WHEN IT WAS BROUGHT INTO THE ROOM TO GET THE PATIENT OFF THE TABLE. PROVIDED PICTURES SHOW THAT NOT ONLY THE CAP OF THE EMERGENCY STOP BUTTON WAS MISSING, BUT THAT THE WHOLE SWITCH WAS TORN OFF THE TABLE. THERE WERE NO INJURIES ASSOCIATED WITH THE EVENT. TWO RISKS ARE SEEN IN THIS CASE: IF THE OPERATOR CONTINUES TO USE THE SYSTEM WITH THE DEFECTIVE EMERGENCY STOP SWITCH, A COLLISION MIGHT NOT BE PREVENTED IN AN EMERGENCY SITUATION, IF THE USER DOES NOT PRESS AN ALTERNATIVE EMERGENCY STOP BUTTON. THIS MIGHT RESULT IN WORST CASE IN A SERIOUS INJURY. IN CASE OF FAILURE OF THE EMERGENCY STOP AT THE TABLETOP, THE USER CAN STOP ANY MOVEMENT IMMEDIATELY WITH FURTHER EMERGENCY STOP BUTTONS LOCATED ON THE BUCKY WALL STAND (IF AVAILABLE) AND ON THE CONTROL ROOM MODULE / REMOTE CONTROL CONSOLE. THE SECOND RISK SEEN IN THIS SPECIFIC CASE IS THAT BODY PARTS OF A PERSON MIGHT HAVE BEEN CRUSHED BETWEEN THE TABLETOP AND THE PATIENT BED, SINCE THE PROVIDED PICTURES SUGGEST THAT THE TABLE WAS DRIVEN DOWNWARDS ONTO THE PATIENT BED: THE COVER OF THE EMERGENCY STOP SWITCH WAS TORN AWAY FROM THE BUMPER AND BENT UPWA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405113 ↗
• MalfunctionJun 6, 2023Device Dislodged or Dislocated; Device Fell; Device Dislodged or Dislocated; Device Fell

  THE CORRUGATED CABLE AND THE BRACKET OF THE LUMINOS AGILE MAX SYSTEM FELL BECAUSE THE SCREW HAD COME OUT. THE CORRUGATED CABLE AND BRACKET WERE REATTACHED WITH A SCREW AND BOLT. NO INJURY WAS COMMUNICATED IN THIS CASE. IN WORST CASE SCENARIO, THE ISSUE MIGHT LEAD TO A MINOR TO SERIOUS INJURY IF A PERSON WERE HIT BY THE FALLING PARTS IF THE ISSUE RECURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17073495 ↗