Uroskop Omnia Max 10762473Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04056869008981), received between Dec 22, 2020 and Dec 15, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Unintended Collision” (6 reports).

2 FDA recall records name this device's identifier, 2 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. Jun 4, 2025Open, Classified

   A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.

   Z-1982-2025 · Root cause: Device Design · 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-1168-2023 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Unintended Collision; Device Handling Problem; Unintended Collision; Device Handling Problem

  SIEMENS HEALTHINEERS BECAME AWARE OF AN ISSUE ASSOCIATED WITH THE UROSKOP OMNIA MAX SYSTEM. THE SYSTEM WAS DRIVEN INTO AN X-RAY SHIELD BY THE CUSTOMER. THE TUBE COVER WAS DAMAGED DURING THE COLLISION. NO FALLING PARTS WERE MENTIONED BY THE CUSTOMER. THE CUSTOMER DEMOUNTED THE X-RAY SHIELD TO MINIMIZE THE COLLISION RISK. ALTHOUGH NO INJURY OCCURRED DUE TO THIS EVENT, IN A WORST-CASE SCENARIO, PERSONS COULD HAVE BEEN SERIOUSLY INJURED BY FALLING PARTS DUE TO A COLLISION OF THE SYSTEM WITH EXTERNAL OBJECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803958 ↗
• MalfunctionNov 24, 2025Unintended Collision; Unintended Collision

  SIEMENS HEALTHINEERS BECAME AWARE OF AN ISSUE ASSOCIATED WITH THE UROSKOP OMNIA MAX SYSTEM. THE SYSTEM WAS DRIVEN INTO AN OPERATING ROOM LIGHT ARM ELBOW. NO MENTION OF FALLING PARTS DUE TO THE COLLISION OR RESULTING INJURY WAS MADE TO SIEMENS HEALTHINEERS. IN A WORST-CASE SCENARIO, SERIOUS INJURY COULD RESULT FROM A COLLISION OF THE SYSTEM WITH EXTERNAL OBJECTS IF PARTS WERE TO FALL DOWN AND HIT A PERSON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632370 ↗
• MalfunctionNov 10, 2025Unintended Collision; Use of Device Problem; Unintended Collision; Use of Device Problem

  SIEMENS HEALTHINEERS BECAME AWARE OF AN EVENT ASSOCIATED WITH THE UROSKOP OMNIA MAX SYSTEM. DURING AN INTERVENTION THE SYSTEM WAS DRIVEN INTO THE SWIVEL ARM OF AN EXTERNAL OBJECT MOUNTED TO THE CEILING, PRESUMABLY AN OPERATING ROOM LIGHT. THE TUBE ASSEMBLY MOUNT WAS BENT DUE TO THE COLLISION. NO FALLING PARTS WERE MENTIONED. NO INJURY TO THE PATIENT OR STAFF WERE COMMUNICATED. IN A WORST-CASE SCENARIO, SERIOUS INJURY COULD RESULT FROM FALLING PARTS DUE TO A COLLISION OF THE SYSTEM WITH EXTERNAL OBJECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509865 ↗
• MalfunctionAug 8, 2024Device Fell; Device Fell

  SIEMENS HEALTHINEERS BECAME AWARE OF AN ISSUE WITH THE UROSKOP OMNIA MAX SYSTEM. IT WAS COMMUNICATED TO SIEMENS HEALTHINEERS THAT THE 19-INCH MONITOR PROTECTION COVER FELL OFF NEAR THE PATIENT BUT DID NOT HIT THE PATIENT. NO ONE WAS INJURED DURING THE EVENT. IT IS ASSUMED THAT IN A WORST-CASE SCENARIO, SERIOUS INJURY COULD RESULT FROM FALLING PARTS IF THE EVENT WERE TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937102 ↗
• MalfunctionSep 14, 2023Device Fell; Device Fell

  THE PLASTIC COVER ON THE JOINT OF THE MONITOR SUPPORT ARM FELL OFF DURING AN EXAMINATION AND HIT A PATIENT IN THE FACE. NO INJURY OCCURRED. IT WAS COMMUNICATED THAT THE COVER(S) COULD BE CLIPPED BACK ON. THE COVERS CONSIST OF TWO HALF-SHELLS. IT IS CURRENTLY UNCLEAR WHETHER ONE OR BOTH HALF-SHELLS/COVERS FELL OFF AND HOW THE COVER(S) COULD DETACH FROM THE MONITOR SUPPORT ARM. FURTHER INFORMATION WAS REQUESTED FOR INVESTIGATION. EACH HALF-SHELL WEIGHS ONLY ABOUT 100G, BUT, SINCE IN THIS CASE THE PATIENT¿S FACE WAS HIT, IT IS ASSUMED THAT IN WORST CASE SCENARIO A SERIOUS INJURY MIGHT OCCUR IF A COVER WOULD HIT A PERSON¿S EYE WITH A SHARP CORNER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17743538 ↗
• InjuryJul 7, 2022Unintended Collision; Unintended Collision

  THE USER DROVE THE UROKOP OMNIA MAX SYSTEM UPWARDS WHERE IT COLLIDED INTO A SURGICAL LIGHT. NO FALLING PARTS WERE MENTIONED. NO PATIENT INVOLVEMENT OR INJURY WAS COMMUNICATED FOR THIS EVENT. IN WORST CASE SCENARIO, PERSONS COULD BE SERIOUSLY INJURED BY FALLING PARTS DUE TO A COLLISION OF THE SYSTEM WITH EXTERNAL OBJECTS. THE ISSUE IS REPORTED WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN GERMANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14946271 ↗
• MalfunctionJun 30, 2021Unintended Collision; Unintended Movement; Unintended Collision; Unintended Movement

  SIEMENS BECAME AWARE OF AN EVENT WITH THE UROSKOP OMNIA MAX UNIT. THE SYSTEM WAS BADLY DAMAGED DURING A COLLISION WITH A TROLLEY. ACCORDING TO THE USER, THE OPERATOR WAS PRESSING THE BUTTON ON THE CONTROL PANEL TO ROTATE THE TABLE COUNTERCLOCKWISE. THE OPERATOR RELEASED THE BUTTON AND WALKED OVER TO THE PATIENT ON THE TABLE, HOWEVER, THE TABLE CONTINUED TO MOVE AND HIT THE TROLLEY. IT THEN STOPPED AND MOVED SLIGHTLY CLOCKWISE. NO INJURY WAS COMMUNICATED FOR THIS EVENT. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12092829 ↗
• MalfunctionDec 22, 2020Unintended Collision; Use of Device Problem; Unintended Collision; Use of Device Problem

  SIEMENS WAS INFORMED ABOUT AN INCIDENT THAT OCCURRED WITH THE UROSKOP OMNIA MAX DEVICE. THE USER DROVE THE TUBE ASSEMBLY INTO A SURGICAL LIGHT. THIS COLLISION RESULTED IN A DENT IN THE TUBE COVER AND A CRACK IN THE TOP COVER. NO FALLING PARTS WERE REPORTED TO SIEMENS. THE X-RAY FIELD REMAINED CENTERED. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11059654 ↗