Mammomat Inspiration 10140000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04056869009063), received between Nov 10, 2020 and Jun 5, 2024 — classified as 3 injuries, 5 malfunctions.

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

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

5 other recalls cover devices cleared under the same FDA submission (K122286, K123520); 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-0879-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

2. 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-0878-2026 · Root cause: Component design/selection · Recall details · 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.

• InjuryJun 5, 2024Use of Device Problem; Use of Device Problem

  SIEMENS HEALTHINEERS WAS MADE AWARE OF A SERIOUS INJURY INVOLVING THE MAMMOMAT INSPIRATION SYSTEM. WHILE ASSISTING WITH THE REPLACEMENT OF THE VERTICAL GEAR MOTOR WITHIN THE MAMMOMAT SYSTEM, THE LIFT WAGON HOLDING THE SWIVEL ARM, TUBE, AND DETECTOR, DROPPED DOWN. PARTS OF THE ASSEMBLY THEREBY FELL ONTO THE SIEMENS CUSTOMER SERVICE ENGINEER´S (CSE) HANDS RESULTING IN A CRUSHING INJURY. THE CSE SUSTAINED FRACTURES TO ONE HAND AND A SEVERE CUT/PUNCTURE WOUND TO THE OTHER. HE WAS TAKEN TO THE EMERGENCY ROOM IMMEDIATELY. SURGERY WAS REQUIRED TO TREAT THE INJURIES. THE CSE WAS RELEASED FROM THE HOSPITAL (DATE UNKNOWN) AND IS NOW HOME. HE WILL BE OUT OF WORK FOR 6-8 WEEKS WHILE HE RECOVERS.

  Patient problems: Bone Fracture(s); Laceration(s)

  MAUDE report 19466603 ↗
• MalfunctionAug 21, 2023Break; Break

  THE USER STATED THAT THE RADIATION PROTECTION SHIELD WAS FOUND TO BE BROKEN BEFORE STARTING EXAMINATIONS. PROVIDED PICTURES SHOW THAT ONLY A SMALL PART OF THE SHIELD WAS STILL LEFT IN PLACE. THE REST OF THE SHIELD HAD DISINTEGRATED INTO SMALL FRAGMENTS THAT WERE LYING ON THE FLOOR AND THE CONSOLE. ACCORDING TO INFORMATION RECEIVED, NO INJURY OCCURRED DUE TO THE EVENT. IT IS CURRENTLY UNCLEAR HOW THE SHIELD, WHICH IS MADE OF SAFETY GLASS, WAS BROKEN. SAFETY GLASS CAN BREAK, AND THIS CANNOT BE COMPLETELY PREVENTED. SHOULD THE SAFETY GLASS PLATE BREAK, NO POINTED OR SHARP-EDGED FRAGMENTS WILL RESULT. THE FRAGMENTS ARE A SQUARE SHAPE AND HAVE NO SHARP OR POINTED EDGES. IT IS ASSUMED THAT IN A WORST-CASE SCENARIO, IF A FRAGMENT WERE TO HIT A PERSON¿S EYE, A SERIOUS INJURY COULD RESULT. THE PROBABILITY FOR THIS TO HAPPEN IS CURRENTLY ASSESSED AS INCONCEIVABLE BY HUMAN ESTIMATION. AS OF THE DATE OF THIS REPORT, SIEMENS HEALTHCARE HAS NOT BEEN MADE AWARE OF ANY SERIOUS INJURY THAT OCCURRED DUE TO A BREAKING SAFETY GLASS SHIELD. THE EVENT WAS REPORTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17585153 ↗
• MalfunctionJun 22, 2022Unintended Collision; Unintended Collision

  THE MAMMOMAT INSPIRATION SYSTEM WAS DRIVEN ONTO A BIOPSY CHAIR RESULTING IN THE CHAIR TO BE CAUGHT UNDER THE SYSTEM AND THE MAMMOMAT INSPIRATION SYSTEM BEING PULLED AWAY FROM THE WALL. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THIS INCIDENT. THE SYSTEM WAS OPERATIONAL AFTER THE EVENT. IN A WORSE-CASE SCENARIO, IF A PATIENT WAS ON THE BIOPSY CHAIR DURING THE EVENT THE PATIENT'S BODY PARTS COULD BE CRUSHED BETWEEN THE SYSTEM AND THE BIOPSY CHAIR DURING A SIMILAR INCIDENT AND A MINOR TO SERIOUS INJURY MIGHT OCCUR THIS EVENT IS BEING REPORT WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN AUSTRALIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14771713 ↗
• InjuryMay 24, 2022Unintended Collision; Unintended Collision

  AN INCIDENT WITH THE MAMMOMAT INSPIRATION UNIT WAS REPORTED. A PATIENT IN A MOTORIZED WHEELCHAIR WAS PRESENT IN THE EXAMINATION ROOM. THE USER DROVE THE TUBE ARM INTO THE WHEELCHAIR WITH THE PATIENT SITTING IN IT. NO INJURY TO PERSONS OR DAMAGE TO THE SYSTEM WERE REPORTED FOR THIS CASE. THE REPORTED INCIDENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14489621 ↗
• MalfunctionApr 5, 2022Unintended Movement; Unintended Movement

  UNINTENDED SYSTEM MOVEMENT WAS REPORTED BY THE USER FOR THE MAMMOMAT INSPIRATION DEVICE. THE USER WAS SEATED ON A STOOL WITH THE UNIT IN A 90-DEGREE POSITION TO PERFORM A LATEROMEDIAL PROJECTION. WHEN THE USER WAS ABOUT TO COMPRESS THE PATIENT'S BREAST, THE UNIT SUDDENLY STARTED TO TURN DOWNWARDS TO 180 DEGREES. THE TUBE GANTRY PUSHED THE OPERATOR OFF THE STOOL WHILE STRIKING THE SHOULDER. FOLLOWING THE DESCRIBED OCCURRENCE, THE EXAMINATION WAS SUCCESSFULLY COMPLETED IN A DIFFERENT PROJECTION (A 45- OR 60-DEGREE POSITION INSTEAD OF 90 DEGREES), AND THE UNIT ROTATED NORMALLY. THE ISSUE DID NOT LEAD TO REPEATED RADIATION EXPOSURE. THERE ARE NO INJURIES ATTRIBUTED TO THE EVENT AS THE PATIENT WAS NOT YET COMPRESSED. NO INJURIES TO THE OPERATOR WERE COMMUNICATED EITHER. THE REPORTED INCIDENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14013636 ↗
• MalfunctionJan 27, 2022Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  GRINDING NOISES WERE COMING FROM THE MAMMOMAT INSPIRATION UNIT DURING SYSTEM MOVEMENT. SIEMENS LOCAL SERVICE ENGINEER INSPECTED THE UNIT, AND WHEN THE COVERS WERE REMOVED, FOUND 4 BOLTS THAT ATTACH THE TUBE ARM ASSEMBLY TO THE STAND HAD STARTED TO BECOME LOOSE. THE ENGINEER REMOVED THE BOLTS, ADDED LOCTITE TO THEM AND RE-INSTALLED THE BOLTS. THE CONCERNED UNIT WAS CHECKED FOR FREE MOVEMENT AND RETURNED TO THE CUSTOMER FOR MOBILE USE. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367118 ↗
• MalfunctionDec 18, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO SIEMENS THAT DURING SERVICE ACTIVITIES MULTIPLE CRACKS IN THE TUBE ARM FRAME AND SOME BROKEN PIECES WERE NOTICED ON THE MAMMOMAT INSPIRATION UNIT. ONLY FRONT BOLTS WERE HOLDING THE TUBE ARM IN PLACE. THE SYSTEM STABILITY COULD NO LONGER BE GUARANTEED. THE CONCERNED UNIT IS A MOBILE SYSTEM AND INSTALLED ON A BUS TRAILER. IT IS ASSUMED THAT THE ISSUE IS CAUSED BY IMPROPER TRANSPORTATION. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11037784 ↗
• InjuryNov 10, 2020No Apparent Adverse Event; Device Handling Problem; No Apparent Adverse Event; Device Handling Problem

  IT WAS REPORTED THAT SIEMENS SERVICE ENGINEER RECEIVED AN ELECTRICAL SHOCK TO HIS FINGER ON THE RIGHT HAND WHILE REPLACING A MAIN FILAMENT INVERTER (MFI) BOARD ON THE MAMMOMAT INSPIRATION UNIT. THE ENGINEER FOLLOWED-UP THE INCIDENT WITH A HOSPITAL CHECK-UP AND ECG EXAMINATION. NO ABNORMALITIES WERE REPORTED. THERE IS NO PATIENT INVOLVEMENT IN THIS CASE. NO INJURIES ARE ATTRIBUTED TO THIS EVENT. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10816043 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122286, K123520. One submission often covers many models, so check the product and lot details in each record.

• Z-1118-2017 · Jan 11, 2017 · Terminated
  Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and ster
• Z-0523-2015 · Oct 28, 2014 · Terminated
  Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic image
• Z-0086-2015 · Sep 18, 2014 · Terminated
  Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the sup
• Z-1638-2014 · Apr 25, 2014 · Terminated
  MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
• Z-1694-2013 · Feb 28, 2013 · Terminated
  Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography