Selenia Dimensions ASY-01966Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 15420045505582), received between Nov 23, 2016 and Dec 22, 2023 — classified as 3 injuries, 128 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (45 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 131 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE SELENIA DIMENSIONS C-ARM WAS MOVING ON ITS OWN. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND FOUND THAT THE TUBEHEAD CONTINUED TO MOVE TRYING TO FIND TOMO ZERO HOME. ADJUSTMENTS WERE MADE TO THE VTA BACKLASH HARDWARE AND A ROTATIONAL DRAG BRAKE WAS INSTALLED. THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS. NO STAFF OR PATIENT INJURY WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18381387 ↗
• MalfunctionNov 10, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON OCTOBER 26TH THAT THE C-ARM WAS MOVING UP AND DOWN EXPOSURES, AND WAS MOVING ON ITS OWN. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND REPLACED THE SWITCHES BANKS AND THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS. NO INJURY TO THE PATIENT NOR STAFF. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18115301 ↗
• MalfunctionNov 7, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6), 2023, DURING A SELENIA DIMENSIONS PROCEDURE, THE C-ARM CONTINUED TO GO FROM 90 ° TO 135 ° WITHOUT THEM HITTING THE SWITCH ON THE RIGHT SIDE OF THE C-ARM. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND FOUND THE BANK SWITCH HAD FAILED. REPLACED BOTH BANK SWITCHES TO RESOLVE THE ISSUE AND TESTED THE SYSTEM OPERATION. THE DEVICE IS WORKING AS PER THE MANUFACTURER´S SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18084268 ↗
• MalfunctionOct 27, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED BY THE CUSTOMER THAT DURING THE ANNUAL SURVEY, THE PHYSICIST FAILED THE UNIT STATING THE GANTRY WAS NOISY / VIBRATING/SKIPPING DURING THE TOMO SWEEP. A FIELD ENGINEER WAS DISPATCHED TO THE SITE, INVESTIGATE THE VTA, AND FOUND 3 BROKEN SCREWS. VTA AND LEADSCREW WERE REPLACED. ALL PERTINENT CALIBRATIONS WERE COMPLETED SUCCESSFULLY. THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS. NO PATIENT INJURY WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022219 ↗
• MalfunctionOct 6, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING A SELENIA DIMENSIONS PROCEDURE THE C-ARM KEPT ROTATING PAST 45 DEGREE ANGLE. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND REPLACED BOTH SWITCH DECKS AND PADDLE SWITCH ASSEMBLY. UPON INSTALLATION THE RIGHT SWITCH DECK DID NOT PERFORMED AS EXPECTED. A FAULTY CONNECTION WAS OBSERVED AND REASSEMBLED. THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS. NO PATIENT INJURY REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17890476 ↗
• MalfunctionJul 27, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6), DURING A SELENIA DIMENSIONS PROCEDURE, THE C-ARM ONLY ROTATES TO 180 WHEN THE STAFF IS ATTEMPTING TO ROTATE 45 DEGREES. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND FOUND THAT THE BUTTONS ARE STICKING ON THE BUTTON BANK, THE BUTTON BANK WAS REPLACED AND THE SYSTEM CONTINUED WORKING UNDER MANUFACTURER´S SPECIFICATIONS. NO PATIENT OR STAFF INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410276 ↗
• MalfunctionFeb 9, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING A SELENIA DIMENSIONS PROCEDURE THE C-ARM MOVED UNCOMMANDED FROM 0 TO 100 DEGREES. NO INJURY TO THE PATIENT OR STAFF REPORTED. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND FOUND THAT THE GANTRY SWITCHES WERE NOT FUNCTIONING. BOTH SWITCHES WERE REPLACED AND THE SYSTEM IS NOT PERFORMING PER MANUFACTURER´S SPECIFICATIONS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16342652 ↗
• MalfunctionJul 22, 2019Break; Break

  IT WAS REPORTED THAT THE GLASS SHIELD HAD SHATTERED. ADDITIONAL INFORMATION WAS RECEIVED THAT NOTED DURING A PATIENT EXAM, WHILE THE PATIENT AND THE TECHNOLOGIST WERE AT THE GANTRY, THE AWS OPERATOR SHIELD SHATTERED. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND THE GLASS SHIELD WAS REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812749 ↗
• MalfunctionSep 17, 2018Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE COMPRESSION DEVICE WAS MOVING DOWNWARD UNCOMMANDED. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THAT THE FOOT SWITCHES NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7881974 ↗
• MalfunctionSep 17, 2018Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT WHEN USING THE FOOT SWITCH, AFTER RELEASING, THE C-ARM CONTINUES TO MOVE IN A DOWNWARD MOTION. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THE FOOT SWITCH NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7881969 ↗
• MalfunctionSep 5, 2018Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE TECHNOLOGIST WAS MOVING THE C-ARM TO A ZERO DEGREE POSITION AND IT CONTINUED ROTATING PAST THAT POSITION. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THE ROTARY SWITCH NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7846999 ↗
• MalfunctionAug 23, 2018Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT WHEN THE C-ARM SWITCH IS ACTIVATED IT IS STICKING CAUSING THE ROTATION TO CONTINUE WHEN THE SWITCH IS RELEASED. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND CONFIRMED THAT ALL SCREWS WERE TIGHT AND CLEANED THE SWITCH. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7810676 ↗
• MalfunctionAug 20, 2018Crack; Crack

  IT WAS REPORTED THAT AS THE TECHNOLOGIST AND PATIENT WERE ENTERING THE EXAM ROOM, THE OPERATOR SHIELD SHATTERED. NO PATIENT IMPACT. THE TECHNOLOGIST RECEIVED TWO SUPERFICIAL CUTS ON HER HAND WHICH DID NOT REQUIRE ANY MEDICAL INTERVENTION. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND THE OPERATOR SHIELD WAS REPLACED.

  Patient problems: Laceration(s)

  MAUDE report 7797444 ↗
• MalfunctionAug 20, 2018Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A PATIENT EXAM, THE TECHNOLOGIST WAS POSITIONING THE C-ARM WITH THE FOOT SWITCH. WHEN THE FOOT SWITCH WAS RELEASED THE C-ARM CONTINUED TO MOVE IN AN UPWARD MOTION CAUSING THE PADDLE TO BE KNOCKED OFF THE SYSTEM WHEN IT MADE CONTACT WITH THE FACE SHIELD. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND IT WAS DETERMINED THAT THE FOOT SWITCHES AND PADDLE NEEDED TO BE REPLACED AND THE CDI SOFTWARE NEEDED TO BE RELOADED. ONCE THIS WAS COMPLETE THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7797212 ↗
• MalfunctionAug 10, 2018Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT WHEN THE TECHNOLOGIST WAS POSITIONING THE C-ARM, IT WAS PASSING THE INTENDED POSITION AND CONTINUED ROTATING. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND A FULL REBOOT OF THE SYSTEM WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7772196 ↗
• MalfunctionAug 10, 2018Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE C-ARM ROTATIONAL ISSUE OF CONTINUED ROTATION PASSED THE INTENDED STOP POSITION HAD REOCCURRED. SEE ASSOCIATED MEDWATCH, MANUFACTURER'S REPORT # 122984-2018-00128. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. THE C-ARM DEFAULT POSITIONS, CRM SOFTWARE, AND CALIBRATION DATA WERE RELOADED. THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7772193 ↗
• MalfunctionJul 17, 2018Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A NEEDLE LOCALIZATION PROCEDURE THE TECHNOLOGIST WAS POSITIONING THE PATIENT AND THE C-ARM ROTATED DOWNWARD AND IMPACTED HER SHOULDER. NO PATIENT IMPACT. THE TECHNOLOGIST WAS EVALUATED AND AN X-RAY WAS DONE WITH NORMAL RESULTS. SHE HAD DISCOMFORT, BUT NO REDNESS OR BRUISING AND NO FURTHER MEDICAL INTERVENTION WAS NEEDED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND IT WAS DETERMINED THAT THE C-ARM CONTROL SWITCHES NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM IS WORKING AS INTENDED.

  Patient problems: Not Applicable

  MAUDE report 7694321 ↗
• MalfunctionJul 17, 2018Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A PATIENT EXAM, AFTER POSITIONING THE PATIENT AND GETTING READY TO TAKE AN EXPOSURE, THE C-ARM MOVED FROM 90 TO 94 DEGREES UNCOMMANDED. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND IT WAS DETERMINED THAT RECALIBRATION OF THE TOMO VTA MOTION WAS NEEDED.

  Patient problems: Not Applicable

  MAUDE report 7694304 ↗
• MalfunctionJul 2, 2018Collapse; Shielding Failure; Collapse; Shielding Failure

  IT WAS REPORTED THAT THE GLASS OPERATOR SHIELD SHATTERED AFTER BUSINESS HOURS. THERE WAS NO INJURY REPORTED AND NO ONE WAS NEAR THE SHIELD AT THE TIME. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND THE SHIELD WAS REPLACED.

  Patient problems: Not Applicable

  MAUDE report 7654491 ↗
• MalfunctionJun 29, 2018Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT AS THE TECHNOLOGIST WAS SETTING UP THE ROOM THE C-ARM ROTATED UNCOMMANDED. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND IT WAS DETERMINED THAT THE C-ARM SWITCHES NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: Not Applicable

  MAUDE report 7650825 ↗
• MalfunctionMay 24, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AUTO CENTER BUTTONS ON THE RIGHT SIDE OF C-ARM ARE NOT WORKING, WHICH IS CAUSING SWEEPING MOTION. NO INJURY WAS REPORTED. IT WAS DETERMINED THAT THE C-ARM SWITCHES NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: Not Applicable

  MAUDE report 7540006 ↗
• MalfunctionMay 24, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE C-ARM ROTATED UNCOMMANDED, PAST THE NORMAL DETENTS. NO INJURY WAS REPORTED. IT WAS DETERMINED THAT THE CIRCUIT BOARD NEEDED TO HAVE THE DETENTS ACTIVATED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: Not Applicable

  MAUDE report 7540004 ↗
• MalfunctionMay 8, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE C-ARM ROTATED UNCOMMANDED. NO INJURY WAS REPORTED. IT WAS DETERMINED THAT THE C-ARM SWITCHES NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: Not Applicable

  MAUDE report 7494709 ↗
• InjuryFeb 13, 2018Human-Device Interface Problem; Physical Property Issue; Human-Device Interface Problem; Physical Property Issue

  IT WAS REPORTED TO OUR FIELD ENGINEER WHEN HE ARRIVED ONSITE LATER IN THE DAY ON (B)(6) 2018, THAT THE MORNING AFTER THE TECHNICIAN HAD FINISHED THE PART OF QA THAT USED THE MAG STAND, SHE HAD GONE BEHIND THE SYSTEM, PLACED THE MAG STAND DOWN. WHEN SHE WENT TO TURN IN THE SMALL SPACE, THEY HAD WHEN SHE LIFTED HER FOOT TO STEP OVER THE FOOT PEDAL WIRE IT MUST HAVE LOOPED OVER HER FOOT AND AS SHE MOVED FORWARD, TIGHTENED AND SHE FELL. SHE WAS TAKEN TO THE EMERGENCY ROOM FOR X-RAYS. SHE RECEIVED A FRACTURE OF THE LEFT WRIST AND A TINY CHIP OFF THE END OF THE ULNA BONE. THEY PUT A SPLINT ON HER WRIST AND WAS BACK TO WORK IN A COUPLE OF DAYS.

  Patient problems: Fall; Fracture, Arm

  MAUDE report 7267653 ↗
• MalfunctionJan 19, 2018Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT GRIDLINES WERE SEEN ON A PATIENT IMAGE, WHICH REQUIRED THE PATIENT TO BE RE-EXPOSED. UNABLE TO REPRODUCE THE ISSUE, CUSTOMER WILL CONTINUE TO MONITOR.

  Patient problems: Not Applicable

  MAUDE report 7207666 ↗

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