Multitom Rax 10860700Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04056869009179), received between Nov 10, 2020 and Aug 11, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (2 reports).

25 other recalls cover devices cleared under the same FDA submission (K152928, K173639, K212212, K221281); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionAug 11, 2021Unintended Movement; Unintended Movement

  SIEMENS BECAME AWARE OF UNINTENDED SYSTEM MOVEMENT OF THE MULTITOM RAX DEVICE. THE 3D TUBE STAND MOVED TO POSITION WITHOUT GIVEN COMMAND. THE USER WAS PREPARING FOR A PATIENT EXAM; WHEN THE EXAM WAS OPENED ON THE FLC, THE TUBE STAND IMMEDIATELY STARTED MOVING AND ALIGNED ITSELF TO A WALL STAND OGP (ORGAN PROGRAM) POSITION, THOUGH, THE EXAMINATION WAS WRIST COMPLETE. NONE OF THE OGPS IN THIS EXAM INCLUDED WALL POSITIONS. THE REPORTED ISSUE OCCURRED TWICE. FOLLOWING THE FIRST OCCURRENCE, THE SYSTEM LOCKED UP IN A WALL POSITION; THE USER HAD TO REBOOT TO ATTEMPT THE EXAMINATION AGAIN. DURING THE SECOND ATTEMPT, THE SYSTEM MOVED TO A WALL POSITION AGAIN ONCE THE EXAM WAS OPENED, HOWEVER, THE UNIT DID NOT LOCK UP AND THE OPERATOR WAS ABLE TO MOVE THE TUBE STAND MANUALLY TO THE CORRECT POSITION AND COMPLETE THE EXAM. THE OVERHEAD TUBE AVOIDED PATIENT CONTACT WHILE IN MOTION. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306681 ↗
• InjuryNov 30, 2020Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED ON THE MULTITOM RAX UNIT. THE USER REPORTED THAT A SURGICAL INTERVENTION COULD NOT BE COMPLETED AND AN IMPLANT COULD NOT PLACED DUE TO INCORRECT MEASUREMENTS OF A TIBIA IMPLANT SHOWN ON X-RAY IMAGES. AN IMAGE WAS NOT SCALED WITH "REAL SIZE" WHEN VIEWING IN PACS MAKING TIBIA IMPLANT DIMENSION TOO LONG TO BE INSERTED IN A PATIENT. THE SURGERY HAD TO BE STOPPED, AND THE PATIENT HAD TO BE AWAKENED. THE USER HAD TO ORDER ANOTHER IMPLANT AND THE SURGERY HAD TO BE REPEATED. HOWEVER, NO MALFUNCTION OF THE MULTITIOM RAX DEVICE WAS IDENTIFIED. SIEMENS IS NOT AWARE OF ANY INJURIES ATTRIBUTED TO THIS EVENT. THE REPORTED INCIDENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10924605 ↗
• InjuryNov 10, 2020Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  SIEMENS WAS INFORMED THAT THE HAND GRIP ON THE MULTITOM RAX UNIT FELL ON THE OPERATOR'S HEAD. IT IS ASSUMED THAT THE HAND GRIP ON THE ORTHO STAND WAS NOT ATTACHED TIGHTLY ENOUGH AND, ONCE THE PATIENT APPLIED TOO MUCH WEIGHT ON THE GRIP, IT SLID DOWN CAUSING THE INCIDENT. THE LABEL ON THE HAND GRIP STATES THAT NO MORE THAN 30KG SHOULD BE APPLIED. THE HAND GRIP CANNOT FALL OFF COMPLETELY AS IT CAN SLIDE UP AND DOWN IN THE RAIL TO THE END POINT. IN THE REPORTED CASE THE USER'S HEAD WAS IN THE WAY OF THE HAND GRIP WHEN IT WAS SLIDING DOWN. X-RAY IMAGES OF THE USER'S HEAD WERE TAKEN AT THE FACILITY. THE USER RECEIVED A BUMP ON THE HEAD. IT WAS COMMUNICATED THAT THERE WAS NO PERMANENT EFFECT OF THE INJURY AND NO OTHER INJURIES WERE REPORTED TO SIEMENS. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10816049 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152928, K173639, K212212, K221281. One submission often covers many models, so check the product and lot details in each record.

• Z-0999-2026 · Dec 5, 2025 · Open, Classified
  LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
• Z-1981-2025 · Jun 4, 2025 · Open, Classified
  UROSKOP Omnia. Model Number: 10094910
• Z-1982-2025 · Jun 4, 2025 · Open, Classified
  UROSKOP Omnia Max. Model Number: 10762473
• Z-2527-2024 · Jul 2, 2024 · Open, Classified
  LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
• Z-2526-2024 · Jul 2, 2024 · Open, Classified
  Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471
• Z-2525-2024 · Jul 2, 2024 · Open, Classified
  Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
• Z-2528-2024 · Jul 2, 2024 · Open, Classified
  Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 10860700
• Z-1165-2023 · Dec 21, 2022 · Open, Classified
  Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
• Z-1167-2023 · Dec 21, 2022 · Open, Classified
  Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
• Z-1168-2023 · Dec 21, 2022 · Open, Classified
  Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473
• Z-1002-2023 · Dec 9, 2022 · Open, Classified
  Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
• Z-1480-2023 · Nov 23, 2022 · Open, Classified
  Luminos dRF Max (VE10, VF10, VF11)
• Z-1481-2023 · Nov 23, 2022 · Open, Classified
  LUMINOS Lotus Max (VF11)
• Z-1479-2023 · Nov 23, 2022 · Open, Classified
  Luminos Agile Max (VE10, VF10, VF11)
• Z-1685-2021 · Apr 20, 2021 · Terminated
  Multitom RAX with software version VF10

…and 10 more.