LUMINOS Lotus Max 11574100Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04056869269931), received between Aug 2, 2023 and Aug 13, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

21 other recalls cover devices cleared under the same FDA submission (K173639); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Dec 5, 2025Class IIOpen, Classified

   A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.

   Z-0999-2026 · Root cause: Radiation Control for Health and Safety Act · Recall details · FDA record ↗

2. Jul 2, 2024Class IIOpen, 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-2527-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Unintended Collision; Unintended Collision

  SIEMENS HEALTHINEERS BECAME AWARE OF AN EVENT ASSOCIATED WITH THE LUMINOS LOTUS MAX SYSTEM. THE CUSTOMER COMMUNICATED WHEN TILTING THE SYSTEM FROM A VERTICAL TO HORIZONTAL POSITION, THE X-RAY TUBE CONTACTED THE CEILING. THE CEILING PLATE LIFTED WITHOUT ANY DAMAGE OR DEFORMATION OF THE X-RAY TUBE. THE SYSTEM WAS BEING PREPARED FOR AN EXAMINATION AND THERE WAS NO PATIENT ON THE TABLE AT THE TIME OF THE EVENT. THERE WERE NO INJURIES RESULTING FROM THE EVENT. IN A WORST-CASE SCENARIO, IF THE EVENT ISSUE WERE TO RECUR, SERIOUS INJURY COULD RESULT FROM FALLING PARTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22800256 ↗
• MalfunctionMar 24, 2025Component Misassembled; Component Misassembled

  SIEMENS HEALTHINEERS DISCOVERED DURING FIELD SAFETY CORRECTIVE ACTION (FSCA) XP018/24/S (RES# (B)(4). THAT THE SECURING SEGMENT OF THE FIXATION FOR THE MONITOR CEILING SUSPENSION WAS NOT INSTALLED CORRECTLY. 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. 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 21678759 ↗
• MalfunctionMar 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS DISCOVERED DURING FIELD SAFETY CORRECTIVE ACTION (FSCA) XP018/24/S (RES# (B)(4)) THAT 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 21630458 ↗
• MalfunctionJul 23, 2024Installation-Related Problem; Installation-Related Problem

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE RELATED TO CUSTOMER SAFETY ADVISORY NOTICE XP017/24/S WITH THE LUMINOS LOTUS MAX SYSTEM. AT THE ATTACHMENT OF MONITOR CEILING SUSPENSION, THE SECURING SEGMENT WAS NOT INSTALLED CORRECTLY. THE MONITOR SUPPORT ARM REMAINED ATTACHED TO THE CEILING AND NO INJURY OCCURRED. 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 19804313 ↗
• MalfunctionMay 8, 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 LOTUS MAX SYSTEM ON (B)(6) 2024. WHEN THE OPERATOR POSITIONED A CENTERING CONE ACCESSORY IN THE COLLIMATOR RAILS, THE ACCESSORY FELL ON THE TABLE. THIS CAUSED TWO DENTS IN THE TABLE THAT RESULTED IN IMAGE ARTIFACTS. THERE WAS NO PATIENT INVOLVEMENT DURING THE EVENT AND NO INJURY TO THE OPERATOR. ADDITIONAL INFORMATION RECEIVED BY SIEMENS HEALTHINEERS ON APRIL 30, 2024, AND MAY 6, 2024. WITH THIS ADDITIONAL INFORMATION, SIEMENS HEALTHINEERS DETERMINED THAT DUE TO THE SPECIFIC DAMAGE TO THE RAILS THE ACCESSORY COULD HAVE FALLEN WHILE A PATIENT WAS LYING ON THE TABLE. IN A WORST-CASE SCENARIO, A SERIOUS INJURY MIGHT HAVE BEEN THE OUTCOME IF THE CONE HAD HIT A PATIENT LYING ON THE TABLE. WITH THE NEW AWARENESS DATE OF(B)(6) 2024, IT WAS DETERMINED THAT THE ISSUE WAS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19267262 ↗
• MalfunctionDec 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  SIEMENS HEALTHINEERS WAS MADE AWARE THAT THE SCREW SECURING THE CABLE HOLDER TO THE CEILING RAIL BECAME LOOSE. THIS CAUSED THE HOLDER AND THE CABLE TO DROP DOWN FROM THE CEILING. THE HOLDER WAS REATTACHED ACCORDING TO THE INSTALLATION INSTRUCTION. NO INJURY WAS COMMUNICATED IN THIS CASE. IN WORST CASE THE ISSUE MIGHT LEAD TO A MINOR TO SERIOUS INJURY IF A PERSON WERE HIT BY THE FALLING PARTS, SHOULD THE ISSUE RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18273873 ↗
• MalfunctionAug 2, 2023Use of Device Problem; Use of Device Problem

  THE OPERATOR POSITIONED THE MONITOR SUPPORT ARM ABOVE THE PATIENT TABLE. WHEN THE OPERATOR RAISED THE SYSTEM UPWARDS, IT COLLIDED WITH THE MONITOR SUPPORT ARM. THE PROVIDED PICTURES SHOW CONSIDERABLE DAMAGE TO THE SUPPORT ARM. THE SUPPORT ARM IS STILL MOUNTED TO THE CEILING AND NO INJURY WAS COMMUNICATED IN THIS CASE. HOWEVER, IT IS ASSUMED THAT IN WORST-CASE SCENARIO, SUCH A COLLISION MIGHT LEAD TO A SERIOUS INJURY IN THE EVENT LARGE SYSTEM PARTS WERE TO FALL AND STRIKE A PERSON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17441616 ↗

Recalls under the same FDA submission

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

• Z-1982-2025 · Jun 4, 2025 · Open, Classified
  UROSKOP Omnia Max. Model Number: 10762473
• Z-1981-2025 · Jun 4, 2025 · Open, Classified
  UROSKOP Omnia. Model Number: 10094910
• 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-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-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-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-1002-2023 · Dec 9, 2022 · Open, Classified
  Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
• 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-1480-2023 · Nov 23, 2022 · Open, Classified
  Luminos dRF Max (VE10, VF10, VF11)
• Z-0806-2021 · Sep 9, 2020 · Terminated
  Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourol
• Z-2757-2020 · Jan 8, 2020 · Terminated
  SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image
• Z-1332-2020 · Jan 8, 2020 · Terminated
  Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image
• Z-1338-2020 · Jan 8, 2020 · Terminated
  Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image

…and 6 more.