Ysio Max 10762470Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04056869004273), received between Jul 21, 2020 and Aug 26, 2025 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2025Device Handling Problem; Device Handling Problem

  SIEMENS HEALTHINEERS BECAME AWARE OF AN EVENT ASSOCIATED WITH THE YSIO MAX SYSTEM. THE CUSTOMER COMMUNICATED THAT WHILE THE PATIENT WAS RECEIVING A WRIST EXAMINATION, THE PATIENT STRETCHED OUT THEIR LEG AND ACCIDENTALLY HIT THE FOOT SWITCH FOR TABLE MOVEMENT AT THE TABLE BASE WITH THEIR FOOT. THIS RESULTED IN THE TABLE BEING LOWERED HITTING THE PATIENT¿S KNEE. THE PATIENT SUSTAINED SKIN ABRASIONS AND REPORTED PAIN. THE TECHNICIAN ON DUTY DISINFECTED THE ABRASIONS AND IMMEDIATELY TOOK AN X-RAY OF THE INJURED AREA. AFTER REVIEWING THE X-RAY, THE DIAGNOSING DOCTOR DID NOT FIND ANY BONE FRACTURES. IN A WORST-CASE SCENARIO, IF THE ISSUE WERE TO RECUR, SERIOUS INJURY COULD RESULT FROM A CRUSHING INJURY.

  Patient problems: Abrasion

  MAUDE report 22892988 ↗
• MalfunctionJun 14, 2024Activation Failure; Activation Failure

  SIEMENS HEALTHINEERS WAS MADE AWARE OF A POTENTIAL PRODUCT PROBLEM ASSOCIATED WITH THE YSIO MAX SYSTEM. THE USER STATED THAT THE MOVEMENT OF THE BUCKY WALL STAND IS NOT BLOCKED WHEN EITHER OF THE TWO EMERGENCY STOP BUTTONS ON THE BUCKY WALL STAND ARE PRESSED. THERE WAS NO USER OR PATIENT INJURY ASSOCIATED WITH THIS ISSUE. IT IS ASSUMED THAT IN A WORST-CASE SCENARIO, A MINOR TO SERIOUS INJURY MIGHT BE THE OUTCOME IF THE EMERGENCY STOPS CANNOT BE ACTIVATED IN AN EMERGENCY SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537845 ↗
• MalfunctionAug 31, 2022Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A PATIENT EXAMINATION THE PATIENT TABLE CONTINUED TO MOVE DOWNWARDS AFTER THE KICK SWITCH WAS RELEASED. THE KICK SWITCH IS LOCATED AT THE BOTTOM OF THE TABLE. THE PATIENT WAS NOT INJURED DURING THIS EVENT. IN A WORST-CASE SCENARIO, A SERIOUS INJURY COULD RESULT IF THE PATIENT IS SITTING IN A WHEELCHAIR WHICH IS LOCATED BENEATH THE TABLE AND THE LOWERING TABLE SQUEEZES THE LEGS OF THE PATIENT. THE REPORTED EVENT OCCURRED IN THE UNITED KINGDOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326560 ↗
• InjuryJun 28, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE PATIENT APPLIED HIS FULL WEIGHT ON THE HANDLES OF THE BUCKY WALL STAND IN PREPARATION FOR A KNEE EXAMINATION. IT IS UNDERSTOOD THAT THE STRETCH GRIPS ARE MEANT FOR USE IN THIS CASE. THE FULL WEIGHT OF THE PATIENT ON THE HANDLES LED TO THE BRAKES OF THE DETECTOR UNIT FAILING AND THE UNIT SLIDING ONTO THE FLOOR. THIS EVENT RESULTED IN THE OPERATOR'S FINGER BEING BROKEN WHILE SHE WAS SQUATTING ON THE FLOOR TO ADJUST THE SYSTEM FOR THE EXPOSURE. THE OPERATOR SUFFERED A FRACTURE OF THE TERMINAL PHALANX OF THE FOURTH FINGER AND A FINGER SPLINT WAS APPLIED. AFTER THIS, SHE WAS ABLE TO RESUME WORK. NO INJURY TO THE PATIENT WAS COMMUNICATED. IT IS ASSUMED THAT IN WORST-CASE SCENARIO THIS ISSUE MIGHT LEAD TO A MODERATE INJURY TO THE PATIENT OR USER. THE OPERATOR'S BROKEN FINGER IS CLASSIFIED AS A MODERATE INJURY; THEREFORE, THE EVENT IS BEING REPORTED WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Bone Fracture(s)

  MAUDE report 14840355 ↗
• InjuryOct 27, 2021Unintended Movement

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED ON THE (B)(6) MAX UNIT. A PATIENT WENT IN FOR EXAMINATION AND WAS SITTING IN A CHAIR NEXT TO THE PATIENT TABLE. WHILE THE TECHNICIAN WAS ADJUSTING THE HEIGHT OF THE PATIENT TABLE, IT MOVED DOWN ONTO THE PATIENTS LEG. THE TECHNICIAN THEN QUICKLY PRESSED THE EMERGENCY BUTTON TO RELEASE THE PATIENT. IT WAS REPORTED THAT PATIENT LEGS WERE PINCHED, AND THIS RESULTED IN THE DISTAL THIGH OF THE PATIENT BEING SWOLLEN. THE REPORTED INCIDENT OCCURRED IN (B)(6).

  Patient problems: Swelling/ Edema

  MAUDE report 12703869 ↗
• InjurySep 2, 2021Unintended Collision; Unintended Collision

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED ON THE YSIO MAX SYSTEM. DURING PATIENT EXAMINATION THE RADIOGRAPHER MOVED THAT TABLE TOP DOWN, TRAPPING A CHILD'S LEG BETWEEN THE TABLE TOP AND THE CHAIR. IT WAS STATED THAT IT WAS NOT POSSIBLE TO MOVE THE TABLETOP UPWARD IMMEDIATELY BUT ONLY AFTER ABOUT ONE SECOND DELAY. EXCEPT FOR SOME REDNESS OBSERVED ON THE CHILD'S LEG, THERE WERE NO INJURIES REPORTED IN THIS CASE. THE INCIDENT OCCURRED IN THE (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12413435 ↗
• InjuryApr 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED ON THE YSIO MAX UNIT. THE STRETCH BAR FOR THE BUCKY WALL STAND BROKE OFF AND FELL ONTO THE PATIENT'S HEAD. THE EXTENT OF PATIENT'S INJURIES HAS NOT YET BEEN PROVIDED TO SIEMENS. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM FOLLOWING THE INCIDENT. ADDITIONAL INFORMATION REGARDING THE INCIDENT HAS BEEN REQUESTED BY SIEMENS.

  Patient problems: Head Injury

  MAUDE report 11728286 ↗
• MalfunctionFeb 16, 2021Unintended Movement; Unintended Movement

  UNINTENDED SYSTEM MOVEMENT OF THE YSIO MAX UNIT WAS REPORTED. DURING PREPARATION FOR AN EXAM, THE OPERATOR TOUCHED THE 3D CEILING STAND, AND IT MOVED WITHOUT UNEXPECTEDLY. THE 3D COLLIDED WITH THE BUCKY WALL STAND. NO PATIENT WAS PRESENT IN THE EXAM ROOM. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT. THE REPORTED INCIDENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11333188 ↗
• MalfunctionJul 21, 2020Use of Device Problem; Use of Device Problem

  A USER OF THE YSIO MAX UNIT SHARED WITH SIEMENS THEIR CONCERNS THAT IN THE UNLIKELY EVENT THAT A PATIENT FALLS DURING AN ORTHO EXAMINATION, HOSPITAL PERSONNEL WOULD NOT BE ABLE TO MOVE THE 3D STAND OUT OF THE WAY QUICKLY ENOUGH AS THE SYSTEM CANNOT BE UNLOCKED FOR MANUAL MOVEMENT IN LONGITUDINAL OR TRANSVERSE DIRECTION WHILE PERFORMING ORTHO STUDIES AT THE WALL BUCKY. THERE IS NO PATIENT INVOLVEMENT REPORTED IN THIS CASE. NO INJURIES ARE ATTRIBUTED TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10302476 ↗