MAMMOMAT Revelation 11343300Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04056869124575), received between Jan 14, 2020 and Apr 8, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K173408, K193166); 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. Oct 24, 2025Class IIOpen, Classified

   There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

   Z-0877-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Material Fragmentation

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE WITH THE MAMMOMAT REVELATION SYSTEM. THE CUSTOMER COMMUNICATED THAT WHEN THEY ARRIVED ONSITE IN THE MORNING, THEY FOUND THE PROTECTIVE GLASS SHIELD ON THE CONSOLE HAD SHATTERED. NO INJURY WAS COMMUNICATED TO SIEMENS HEALTHINEERS AS A RESULT OF THIS EVENT. IT IS ASSUMED THAT IN WORST-CASE SCENARIO, A SERIOUS INJURY MIGHT OCCUR DUE TO THE FLYING PIECES OF GLASS. AS OF THE DATE OF THIS REPORT, SIEMENS HEALTHINEERS HAS NOT BEEN MADE AWARE OF ANY INJURY THAT HAS OCCURRED DUE TO A BREAKING RADIATION GLASS SHIELD, HENCE THE PROBABILITY FOR A SERIOUS INJURY TO BE THE OUTCOME IS CURRENTLY ASSESSED WITH A FREQUENCY OF INCONCEIVABLE. HOWEVER, THIS ISSUE IS REPORTED WITH AN ABUNDANCE OF CAUTION BECAUSE THIS EVENT COULD POTENTIALLY OCCUR AT ANY POINT IN TIME WITH PERSONS NEARBY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24814792 ↗
• MalfunctionMar 4, 2026Installation-Related Problem

  AN OPERATOR TABLE INTENDED FOR STATIONARY USE WAS INSTALLED IN A MOBILE VEHICLE. IF THE USER DOES NOT NOTICE A POTENTIALLY LOOSE MONITOR AFTER TRANSPORTATION, IN A WORST-CASE SCENARIO, THIS ISSUE COULD LEAD TO A MINOR TO SERIOUS INJURY. NO LOOSE MONITOR WAS COMMUNICATED IN THIS CASE. NO INJURY WAS COMMUNICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507681 ↗
• MalfunctionMar 4, 2026Installation-Related Problem

  AN OPERATOR TABLE INTENDED FOR STATIONARY USE WAS INSTALLED IN A MOBILE VEHICLE. IF THE USER DOES NOT NOTICE A POTENTIALLY LOOSE MONITOR AFTER TRANSPORTATION, IN A WORST-CASE SCENARIO, THIS ISSUE COULD LEAD TO A MINOR TO SERIOUS INJURY. NO LOOSE MONITOR WAS COMMUNICATED IN THIS CASE. NO INJURY WAS COMMUNICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507676 ↗
• MalfunctionMay 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  SIEMENS HEALTHINEERS BECAME AWARE OF AN ISSUE WITH THE MAMMOMAT REVELATION SYSTEM IN TRUCK/BUS INSTALLATION. IT WAS STATED THAT DURING TRANSIT THE FRONT PANEL OF THE SYSTEM MONITOR INSTALLED IN THE MOBILE TRUCK FELL DOWN. 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 A PERSON BEING HIT BY FALLING PARTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095092 ↗
• MalfunctionMay 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  SIEMENS HEALTHINEERS BECAME AWARE OF AN ISSUE WITH THE MAMMOMAT REVELATION SYSTEM IN TRUCK/ BUS INSTALLATION. IT WAS STATED THAT DURING TRANSIT THE SYSTEM MONITOR INSTALLED IN THE MOBILE TRUCK FELL DOWN AND BROKE INTO TWO PIECES. 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 A PERSON BEING HIT BY FALLING PARTS IF THE USER DID NOT NOTICE THAT THE MONITOR HAD LOOSENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095038 ↗
• MalfunctionMay 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  SIEMENS HEALTHINEERS BECAME AWARE OF AN ISSUE WITH THE MAMMOMAT REVELATION SYSTEM IN TRUCK/ BUS INSTALLATION. IT WAS STATED THAT DURING TRANSIT, THE FRONT PANEL OF THE SYSTEM MONITOR INSTALLED IN THE MOBILE TRUCK, FELL DOWN. 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 A PERSON BEING HIT BY FALLING PARTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095002 ↗
• MalfunctionJun 24, 2022Retraction Problem; Positioning Problem; Retraction Problem; Positioning Problem

  DURING A BIOPSY PROCEDURE THE USER HAD PROBLEMS REMOVING THE NEEDLE FROM THE PATIENT'S BREAST AND RELEASING THE PATIENT FROM THE MAMMOMAT REVELATION SYSTEM IN A TIMELY MANNER. THE SWIVEL ARM COULD NOT BE ROTATED AS INTENDED. AFTER DECOMPRESSING THE PATIENT'S BREAST, MOVEMENT WAS ENABLED AGAIN. NO OTHER INJURY THAN THE PROBLEMS WITH RELEASE WAS REPORTED. THE ISSUE WILL BE CLASSIFIED AS REPORTABLE WITH AN ABUNDANCE OF CAUTION IN CONSIDERATION TO A WORST-CASE SCENARIO AND THE RESPECTIVE PSYCHOLOGICAL EFFECTS ON THE PATIENT IF RELEASE TAKES A SIGNIFICANT TIME EVEN THOUGH THE RESPECTIVE INJURY WOULD BE CLASSIFIED AS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14797768 ↗
• MalfunctionNov 30, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

  SIEMENS BECAME AWARE OF AN INCIDENT ON THE MAMMOMAT REVELATION MACHINE. DURING A RECENT INSTALLATION THE RADIATION GLASS WAS PUT IN PLACE ON THE OPERATING TABLE. HOWEVER, A SLIGHT IMPACT BETWEEN THE GLASS AND A METAL ELEMENT LOCATED IN THE LOCATION OF THE GLASS CAUSED THE GLASS TO EXPLODE. THE GLASS SHATTERED INTO SMALL PIECES. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12892073 ↗
• InjuryNov 23, 2021Unintended Movement; Unintended Movement

  SIEMENS BECAME AWARE OF AN INCIDENT ON THE MAMMOMAT REVELATION MACHINE. A PATIENT WAS LYING ON A TROLLEY (BIOPSY CHAIR) WITH THE TROLLEY BEING IN A LOCKED POSITION. A SCOUT IMAGE AND STEREO PAIR WERE TAKEN; THE BIOPSY NEEDLE WAS NOT INSERTED IN THE PATIENT. THE X-RAY TUBE STARTED TO MOVE DOWN AND TRAPPED THE PATIENT RESULTING IN THE FRACTURE OF THE RADIAL BONE. FURTHERMORE, IT IS STATED THAT NO ONE WAS NEAR THE STAND WHEN IT MOVED. THE REPORTED INCIDENT OCCURRED IN THE UNITED KINGDOM.

  Patient problems: Bone Fracture(s)

  MAUDE report 12859974 ↗
• MalfunctionJul 24, 2020Use of Device Problem; Use of Device Problem

  SIEMENS WAS INFORMED THAT A PATIENT COLLAPSED DURING A BIOPSY EXAM ON THE MAMMOMAT REVELATION UNIT. DURING THE EVENT THE CUSTOMER COULD MOVE THE ARM ONLY ±6°. EVEN THOUGH THE USER FOLLOWED THE INSTRUCTIONS PROVIDED IN THE CUSTOMER SAFETY ADVISORY NOTICE XP011/20/S (RES 85719), THE OPERATOR WAS UNABLE TO RELEASE THE PATIENT FROM THE BIOPSY UNIT IMMEDIATELY FOLLOWING THE COLLAPSE. THE USER CALLED SIEMENS LOCAL SERVICE FOR ASSISTANCE. SERVICE WAS ABLE TO PROVIDE INSTRUCTIONS TO RELEASE THE PATIENT FROM THE UNIT. AT THIS POINT IN TIME IT IS NOT CLEAR IF THE PATIENT COLLAPSED IN STANDING OR SITTING POSITION. NO INJURY OR NECESSARY MEDICAL INTERVENTION WAS COMMUNICATED IN THIS CASE. THE REPORTED INCIDENT OCCURRED IN (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10320357 ↗
• MalfunctionJan 14, 2020Use of Device Problem; Output Problem; Use of Device Problem; Output Problem

  SIEMENS WAS INFORMED BY ITS SERVICE ORGANIZATION ABOUT MAMMOMAT REVELATION MALFUNCTION THAT OCCURRED DURING A PATIENT EXAMINATION. THE BIOPSY NEEDLE WAS ALREADY INSERTED INTO THE PATIENT'S BREAST WHEN THE SYSTEM DISPLAYED A MESSAGE THAT THE PROCEDURE COULD NOT BE CONTINUED. THE MESSAGE ALSO INDICATED THAT THE USER NEEDED TO REMOVE THE NEEDLE HOLDER. ACCORDING TO THE OPERATOR, THE NEEDLE WAS REMOVED BUT WITH SOME DIFFICULTY. THERE IS NO INJURY ATTRIBUTED TO THIS EVENT. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9586757 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173408, K193166. One submission often covers many models, so check the product and lot details in each record.

• Z-2388-2020 · May 7, 2020 · Terminated
  MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervi
• Z-0160-2020 · Jul 23, 2019 · Terminated
  Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures