Selenia Dimensions ASY-04160Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 15420045505636), received between Oct 5, 2017 and Aug 6, 2024 — classified as 1 injury, 46 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (20 reports).

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

4 other recalls cover devices cleared under the same FDA submission (P010025); 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. Aug 19, 2024Class IIOpen, Classified

   Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosis

   Z-3248-2024 · Root cause: Software design · Recall details · FDA record ↗

2. Jan 16, 2023Class IIOpen, Classified

   C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual

   Z-1144-2023 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE CUSTOMER REPORTED THAT THE C-ARM WAS MOVING ON ITS OWN WITHOUT ANY BUTTONS BEING PRESSED, A FIELD ENGINEER EXAMINED THE EQUIPMENT AND DETERMINED THAT THE BRAKE VOLTAGE DROPS TO ZERO WHEN ENGAGED, THE RESOLUTION WAS TO REPLACE THE TOMO BRAKE AND PERFORMED ALIGNMENT AND CALIBRATION. SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS. NO PATIENT INJURY OR STAFF REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920143 ↗
• MalfunctionJun 26, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A SELENIA DIMENSIONS PROCEDURE ON (B)(6) 2024, THE SYSTEM DISPLAYED VTA ERRORS AND THE SYSTEM WENT DOWN. UNCOMMANDED C-ARM MOVEMENT IN VERTICAL MOTION WAS REPORTED. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND DETERMINED THAT THE DRAG BRAKE NEEDED TO BE REPLACED TO RESOLVE THE ISSUE. THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS. NO PATIENT OR STAFF INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19619949 ↗
• MalfunctionMar 8, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6), THAT THE C-ARM FROM THE SELENIA DIMENSION APPEARS TO NOT STOP WHEN SHE RELEASES THE FOOT SWITCH LIKELY A STUCK FOOT SWITCH ISSUE. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND FOUND THAT THE FOOTSWITCH BUTTON NOT RELEASING CAUSING UNINTENDED MOTION, IT WAS REMOVED AND REPLACED FOOTSWITCHES. THE SYSTEM IS FUNCTIONING PROPERLY AND MEETS ALL MANUFACTURER SPECIFICATIONS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866845 ↗
• MalfunctionJul 6, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT A SELENIA DIMENSION PROCEDURE ON JUNE 16TH, AND THE C-ARM ROTATION SWITCH DID NOT WORK DURING THE PROCESS. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND DETERMINED THAT THE ROTATION SWITCH UNDER THE C-ARM WAS DEFECTIVE, THE C-ARM ROTATES EVEN WHEN THE SWITCH IS RELEASED. THE SWITCH WAS REPLACED. THE SYSTEM PASSED ALL TESTS AND MEETS THE MANUFACTURER´S SPECIFICATIONS. NO PATIENT OR STAFF INJURY WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266432 ↗
• MalfunctionJun 16, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A SELENIA DIMENSIONS PROCEDURE ON MAY 23RD, THE C-ARM LOCKS UP WHEN A SYSTEM ERROR HAPPENED. THE C-ARM ALSO DID NOT PROPERLY RETURN TO ZERO. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND DETERMINED THAT THE TOMO ARM DOES NOT GO TO ZERO AND THE C-ARM ROTATED TO 180° ON ITS OWN. DUE TO LEFT SWITCH LOCKOUT FAULTS. THE FIELD ENGINEER REPLACED THE C-ARM TRANSITION AND CONTROL BOARDS AND CALIBRATED THEM AS PER HOLOGIC SPECIFICATIONS. THE SYSTEM PASSED ALL TESTS AND MEETS THE MANUFACTURER´S SPECIFICATIONS. NO PATIENT OR STAFF INJURY REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148529 ↗
• MalfunctionMar 24, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6), 2023, DURING A SELENIA DIMENSIONS PROCEDURE, IT WAS REPORTED THAT THE C-ARM WOULD MOVE ON ITS OWN. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND DETERMINED THAT IT WAS RELATED TO FAULTY SWITCHES. REPLACED THE C-ARM ROTATION SWITCH, AND THE SYSTEM PASSED ALL TESTS AND MEETS THE MANUFACTURERS' SPECIFICATIONS. NO INJURY TO THE PATIENT OR STAFF WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16614412 ↗
• MalfunctionMar 17, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A SELENIA PROCEDURE THE SYSTEM EXPERIENCED UNEXPECTED MOTION. NO PATIENT INJURY OR STAFF REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566496 ↗
• MalfunctionMar 10, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING A SELENIA DIMENSIONS PROCEDURE, IT WAS REPORTED THAT THE C-ARM WOULD MOVE ON ITS OWN. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND DETERMINED THAT IT WAS RELATED TO FAULTY SWITCHES. THE EQUIPMENT WAS REPAIRED AND THE EQUIPMENT MET THE MANUFACTURER´S SPECIFICATIONS. NO INJURY TO THE PATIENT OR STAFF REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526361 ↗
• MalfunctionAug 4, 2022Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT WHILE ROTATING THE C-ARM TO 45 DEGREES IT CONTINUED TO 195 DEGREES BEFORE STOPPING. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THE LEFT AND RIGHT C-ARM SWITCHES NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15163412 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CUSTOMER WAS INJURED WHILE INSTALLING THE MAG STAND ON SYSTEM. THE MAG STAND WAS NOT LATCHED ALL THE WAY AND FELL WHILE THE CUSTOMER STILL HAD A HOLD OF IT, RESULTING IN INJURY OF BOTH INDEX FINGERS. NO SYSTEM SERVICE WAS REQUIRED AS THIS WAS USER ERROR NOT A MALFUNCTION. THE MACHINE IS CURRENTLY OPERATING TO HOLOGIC'S SPECIFICATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 14698490 ↗
• MalfunctionMay 28, 2021Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING POSITIONING THE C-ARM CONTINUED TO MOVE UNTIL IT WAS COMPLETELY UPSIDE DOWN. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THE C-ARM ROTATION SWITCH WAS TOO CLOSE TO THE C-ARM ENCLOSURE SURFACE. RATHER THAN JUST ADJUSTING THE SWITCH POSITION THE SWITCH WAS REPLACED AS A PRECAUTION. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11903105 ↗
• MalfunctionDec 8, 2020Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE FOOT SWITCH WAS CAUSING INTERMITTENT C-ARM MOTION. IF THE FOOT SWITCH WAS BUMPED THE C-ARM WAS MOVING ON ITS OWN. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND WAS NOT ABLE TO REPRODUCE THE REPORTED ISSUE. THE FOOT SWITCH WAS REPLACED AND THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10968295 ↗
• MalfunctionSep 23, 2020Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE ERROR CODES AND THEN THE C-ARM SLOWLY MOVED ON ITS OWN TO THE LOWEST POSITION. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THE LEFT SWITCH BANK NEEDED TO BE REPLACED. ONCE THAT WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10573107 ↗
• MalfunctionSep 23, 2020Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT AN ERROR WAS RECEIVED "ACCOMPANIED BY THE C-ARM LOWERING IT TO THE LIMIT OF MACHINERY." NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THE LEFT AND RIGHT GANTRY FOOTSWITCHES NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10573106 ↗
• MalfunctionMar 16, 2020Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT "WHILE POSITIONING GANTRY TO OBLIQUE POSITION, COMPRESSION ARM, PADDLE AND DETECTOR 'SLIPPED TO FLOOR', 'AS IF IT WASN'T BEING HELD IN PLACE BY BRAKES'." NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THE FOOTSWITCH NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9835722 ↗
• MalfunctionFeb 11, 2020Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE C-ARM CONTINUES TO ELEVATE OR LOWER UNTIL THE SWITCHES ARE PLAYED WITH TO TERMINATE THE MOTION. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THE LEFT AND RIGHT SIDE SWITCHES NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9696027 ↗
• MalfunctionDec 6, 2019Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE C-ARM AUTO MOVE DOWN. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THE FOOTSWITCH NEEDED TO BE REPLACED AND THE CABLE IN PMC NEEDED TO BE RESEATED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9424180 ↗
• MalfunctionNov 18, 2019Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT A PATIENT COMPLAINED OF A SHOCK ON THE TOP OF HER BREAST DURING HER MAMMOGRAM. THE PATIENT WAS EXAMINED AND THERE WERE NO VISIBLE INJURIES AND NO MEDICAL INTERVENTION WAS REQUIRED. THE CUSTOMER NOTED NO ISSUES EXCEPT FOR THE ONE PATIENT. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND FOUND THAT ALL GROUND WIRES WERE WELL SEATED AND RESISTANCE MEASUREMENTS TO GROUND AT ALL EXPOSED METAL POINTS WERE LESS THAN AN OHM WITH THE EXCEPTION OF THE PADDLE SHIFT ASSEMBLY WHICH MEASURED 660 OHMS. MEASURED ALL EXPOSED METAL TO GROUND VOLTAGES AND THE HIGHEST READINGS WERE: 0.004VDC AND 4.6 MILLIVOLTS AC. ALL VOLTAGE MEASUREMENTS FROM NONCONDUCTIVE SURFACES (PADDLES AND BREAST TRAY) WERE ZERO. A BROKEN GROUND WIRE WAS FOUND INSIDE THE GANTRY AND WAS REPLACED. AS A PRECAUTION THE EXTERNAL COMPRESSION DEVICE, EXTERNAL COMPRESSION DEVICE COVERS, LARGE AND SMALL COMPRESSION PADDLES, AND THE BREAST TRAY COVER WERE ALSO REPLACED. THE FIELD ENGINEER FOLLOWED UP WITH THE CUSTOMER ON (B)(6) 2019 AND NO FURTHER INCIDENTS WERE REPORTED. THE SYSTEM IS WORKING AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9336750 ↗
• MalfunctionNov 5, 2019Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE C-ARM ROTATES TOO FAR. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9278223 ↗
• MalfunctionAug 5, 2019Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE C-ARM AUTO MOVED DOWN DURING POSITIONING. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THAT THE FOOTSWITCH NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8861644 ↗
• MalfunctionMay 10, 2019Imprecision; Imprecision

  ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8601143 ↗
• MalfunctionMay 7, 2019Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT WHEN ATTEMPTING TO ROTATE TO THE MLO POSITION, THE MACHINE DOES NOT STOP AT THE 45 DEGREE ANGLE. INSTEAD THE C-ARM WOULD CONTINUE TO ROTATE UNPROMPTED. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8587903 ↗
• MalfunctionJul 9, 2018Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING A PATIENT EXAM, WHERE THERE WAS AN EXPECTATION OF CONTRAST INTAKE, NO CONTRAST WAS VISIBLE IN THE IMAGE. THE IMAGES AND K CALIBRATION DATA FROM THE SYSTEM WERE EVALUATED BY AN IMAGING SCIENTIST AND IT WAS DETERMINED THAT THE SWIRL PHANTOM USED BY THE FIELD ENGINEER FOR THE INITIAL CALIBRATION NEEDED TO BE REPLACED DUE TO DEGRADED PHANTOM QUALITY. THE IMAGING SCIENTIST INSTRUCTED THE CUSTOMER TO MANUALLY UPDATE THE SYSTEM K FACTOR AND PERFORM QC TEST BEFORE AND AFTER THE UPDATE TO CONFIRM IMPROVED IMAGE QUALITY.

  Patient problems: Not Applicable

  MAUDE report 7669914 ↗
• MalfunctionJul 3, 2018Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT AFTER POSITIONING A PATIENT FOR AN EXPOSURE THE C-ARM ANGLED UNCOMMANDED. NO INJURY WAS REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND THE TOMO BRAKE VOLTAGE WAS CORRECTED AND THE TOMO POTENTIOMETER WAS REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: Not Applicable

  MAUDE report 7658869 ↗
• MalfunctionFeb 13, 2018Device Operational Issue; Device Operational Issue

  IT WAS REPORTED BY A TECHNICIAN THAT THE MANUAL COMPRESSION KNOB IS HARD TO TURN AND CAUSED HER TO HAVE THUMB TENDINITIS. THIS HAPPENED IN (B)(6) 2017. THE SITES OCCUPATIONAL THERAPIST DIAGNOSED THE TENDINITIS AND TREATED HER WITH EXERCISES AND TAPE. THE TECHNICIAN JUST REPORTED THE TIGHT TENSION ON THE KNOB AS SHE NOTICED A NEW TECHNICIAN HAD A FINGER THAT LOCKED UP ONCE AND FIGURED IT WAS THE KNOB AS WELL. THAT WAS JUST A ONETIME OCCURRENCE. THE TECHNICIAN HAS HAD NO PROBLEMS SINCE TREATMENT.

  Patient problems: Not Applicable

  MAUDE report 7267652 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010025. One submission often covers many models, so check the product and lot details in each record.

• Z-2167-2026 · Apr 8, 2026 · Open, Classified
  SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-
• Z-1700-2014 · May 13, 2014 · Terminated
  Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography
• Z-2301-2013 · Sep 6, 2013 · Terminated
  Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that ca
• Z-1546-2008 · Feb 28, 2008 · Terminated
  Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full field digital, system, x-ray, mammographic; Model Number: SEL-00002; Hologic, Danbury CT 06810