Affirm Prone Biopsy System PBX-SYS-AFFIRM-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 15420045506510), received between Dec 29, 2017 and May 8, 2026 — classified as 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (14 reports).

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.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Unintended System Motion

  IT WAS REPORTED BY THE USER SITE THAT ON (B)(6) 2026, DURING USE OF AN AFFIRM PRONE BIOPSY SYSTEM, 3D, THE STAGE ARM UNLATCHED DURING A BIOPSY PROCEDURE FOLLOWING THE POST-FIRE IMAGE PAIR. THE USER SITE REPORTED THAT THE STAGE ARM BEGAN REPORTING AS UNLOCKED AND STAFF WERE UNABLE TO PROCEED WITH THE PROCEDURE AS EXPOSURES WERE PREVENTED. IT WAS FURTHER REPORTED THAT THE BIOPSY NEEDLE WAS ALREADY INSERTED IN THE PATIENT¿S BREAST WHEN THE STAGE ARM LOCK RELEASED. THE USER SITE REPORTED THAT THE STAFF ATTEMPTED TO RE-LOCK THE STAGE ARM BUT THE SYSTEM DID NOT UPDATE TO A READY STATUS. THE USER SITE REPORTED THAT THE BIOPSY PROCEDURE WAS PARTIALLY COMPLETED AS THE CALCIFICATIONS WERE OBTAINED, HOWEVER VERIFICATION IMAGES FOR THE MARKER COULD NOT BE ACQUIRED. NO PATIENT INJURIES WERE REPORTED. A FIELD SERVICE ENGINEER (FSE) THE AUTHORIZED DEALER INVESTIGATED THE SYSTEM. THE FSE POWERED DOWN THE SYSTEM AND THE STAGE ARM COVERS WERE REMOVED. THE FSE REMOVED AND REPLACED THE PLUNGER, MOTOR, AND OPTICAL SENSORS ASSOCIATED WITH THE STAGE ARM DETENT MECHANISM. THE FSE ROUTED AND RECONNECTED THE CABLES TO THE CONTROL BOARD AND THE SYSTEM WAS POWERED ON. THE STAGE ARM DETENT CALIBRATION WAS PERF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25131264 ↗
• InjuryJan 21, 2026Calibration Problem

  IT WAS REPORTED BY THE USER SITE THAT DURING A AFFIRM PRONE BIOPSY SYSTEM, 3D PATIENT EXAM ON (B)(6) 2025, THE PROCEDURE WAS ABORTED POST-INCISION DUE TO THE Z-AXIS NOT LINING UP PROPERLY AFTER QAS. THE USER SITE REPORTED THAT THEY WERE UNABLE TO TARGET PROPERLY AND THAT THE BIOPSY WAS RESCHEDULED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE DEVICE. THE FSE CHECKED ALL THE TARGETS OF THE DEVICE AND WAS UNABLE TO REPRODUCE THE PROBLEM. THE FSE DID A DEVICE CALIBRATION AND VERIFIED THE QAS. THE FSE VERIFIED THAT THE SYSTEM IS NOW OPERATING ACCORDING TO MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24135266 ↗
• InjuryNov 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE USER SITE THAT DURING AN AFFIRM PRONE BIOPSY SYSTEM, 3D PROCEDURE ON (B)(6) 2025, THAT THE TARGETING NEEDLE WAS OFF AND IN THE INCORRECT POSITION. THE ISSUE WAS REPORTED TO HAVE OCCURRED WHILE THE PATIENT WAS IN COMPRESSION AND THAT THE PATIENT REMAINED AT THE USER SITE AFTER THE PROCEDURE. THE USER SITE REPORTED THAT A CUT WAS MADE IN THE PATIENT'S SKIN AND THAT THE NEEDLE APPEARED TO ALREADY BE IN BREAST WHEN APPROACHING ITS TARGET. A REMOTE SESSION WAS HELD WITH A HOLOGIC TECHNICIAN SUPPORT AGENT (TS) AND THE CUSTOMER. THE TS REPORTED THAT THE BIOPSY WAS NOT ATTEMPTED BECAUSE THE APERTURE WAS STILL NOT IN THE BREAST. HOWEVER, THE SYSTEM SHOWED THE APERTURE AT THE LESION BECAUSE IT DISPLAYED THE NEEDLE IN A FIRED STATE. THE TS DID A MOCK BIOPSY, AND THE SYSTEM PASSED A QUALITY CHECK. THE TS WAS NOT ABLE TO REPLICATE THE ISSUE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23514265 ↗
• MalfunctionNov 10, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED BY THE USER SITE ON (B)(6) 2025, THAT THE C-ARM ON AN AFFIRM PRONE BIOPSY SYSTEM WAS MOVING "ON ITS OWN" BUT NOW, IS NOT MOVING AT ALL. NO PATIENT OR USER INJURY WAS REPORTED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE DEVICE AND DETERMINED THAT THE C-ARM DID MOVE WITHOUT A VALID COMMAND DUE TO A STUCK ROTATIONAL SWITCH. THE FSE REPORTS THAT ONCE THE UNIT DETECTED THE C-ARM MOTION, A SYSTEM ERROR DISPLAYED WHICH ENGAGED THE SYSTEM SAFETY OVERRIDE AND LOCKED OUT THE SYSTEM SWITCHES, RESULTING IN THE USER BEING UNABLE TO FURTHER MOVE THE C-ARM WITH THE SYSTEM SWITCHES. THE FSE REPORTS THAT BOTH THE LEFT AND RIGHT ROTATIONAL SWITCHES WERE REPLACED, AND THE SYSTEM IS FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511559 ↗
• MalfunctionSep 25, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6) 2025 DURING AN AFFIRM PRONE BIOPSY SYSTEM PROCEDURE, THE USER SITE INDICATED THAT DURING PREFIRE IMAGES, THE FIRST IMAGE WAS NORMAL, HOWEVER WHEN PERFORMING THE SECOND IMAGE, THE STAGE MOVED WITH THE ARM WHILE THE NEEDLE WAS STILL IN THE PATIENT¿S BREAST. ADDITIONALLY, THE CUSTOMER SITE REPORTS THAT THE STAGE ARM WAS LOOSE EVEN THOUGH IT WAS LOCKED. THE USER FURTHER REPORTS THAT THE STAGE ARM WAS PUSHED BACK INTO PLACE AND THE BIOPSY WAS FINISHED WITH NO REPORTED PATIENT INJURY. A HOLOGIC FIELD SERVICE ENGINEER (FE) WAS DISPATCHED TO EXAMINE THE DEVICE AND FOUND THAT THE STAGE MOVED DURING BIOPSY AND THAT THE STAGE ARM CONTROL BOARD LOST COMMUNICATIONS. THE FE REPLACED THE STAGE ARM CONTROL BOARD AND UPLOADED CURRENT CODE CONFIGURATION. THE FE TRANSFERRED NODE CONFIGURATION, PERFORMED QUALITY CHECKS, AND VERIFIED THE SYSTEM IS OPERATING WITHIN MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23143080 ↗
• MalfunctionSep 25, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN AFFIRM PRONE PROCEDURE ON (B)(6) 2025, THE NEEDLE WENT 3CM PAST THE INTENDED TARGET. NO PATIENT OR USER INJURY WAS REPORTED. HOLOGIC TECHNICAL SUPPORT REVIEWED THE SYSTEM LOGS AND FOUND THE PRE-FIRE IMAGE SHOWED THAT THE NEEDLE TIP WAS NOT AT THE TARGET. ADDITIONALLY, IN REVIEWING THE SYSTEM LOGS, IT APPEARED THAT THE NEEDLE IN THE IMAGES DID NOT MATCH THE NEEDLE THAT WAS SELECTED. A HOLOGIC FIELD SERVICE (FSE) WAS ALSO DISPATCHED TO EXAMINE THE SYSTEM. THE FSE RAN QUALITY CHECKS, WHICH THE SYSTEM PASSED WITH NO ISSUES FOUND. FURTHER, THE FSE PERFORMED SEVERAL CALIBRATION CHECKS, WHICH WERE ALSO SUCCESSFUL, AND PASSED WITH NO ISSUES. THE FSE REPORTS THAT THE SYSTEM MEETS ALL MANUFACTURING STANDARDS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23143045 ↗
• InjuryApr 16, 2025Unintended System Motion; Failure to Obtain Sample; Unintended System Motion; Failure to Obtain Sample

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING AN AFFIRM PRONE BIOPSY PROCEDURE, THE STAGE ARM AND NEEDLE BEGAN TO MOVE FREELY WHILE THE NEEDLE WAS INSIDE THE PATIENT'S BREAST. A FIELD ENGINEER EXAMINED THE EQUIPMENT BUT WAS UNABLE TO REPLICATE THE ISSUE. THE FIELD ENGINEER PERFORMED SYSTEM CALIBRATIONS AND CONFIRMED THAT THE SYSTEM IS FUNCTIONING ACCORDING TO MANUFACTURER SPECIFICATIONS. THE PATIENT PROCEDURE WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 21852193 ↗
• InjuryFeb 14, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, WHEN POSITIONING THE NEEDLE DURING AN AFFIRM PRONE PROCEDURE , THE NEEDLE WAS POSITIONED TOO DEEP CAUSING A HEMATOMA. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND IT WAS DETERMINED THAT IT WAS RELATED TO A USER ERROR AS IT IS THE RESPONSIBILITY OF THE CUSTOMER TO ENSURE THAT THE PROPER NEEDLE IS SELECTED FROM THE DROP DOWN AS IT IS DESCRIBED IN THE MANUAL. IN THIS CASE THE CUSTOMER SELECTED THE WRONG NEEDLE WHICH CAUSED THE LENGTH TO BE DIFFERENT THUS CAUSING THE NEEDLE TO GO DEEPER CAUSING THE HEMATOMA.

  Patient problems: Hematoma

  MAUDE report 18705752 ↗
• MalfunctionMay 10, 2021Flare or Flash; Flare or Flash

  IT WAS REPORTED THAT THE CUSTOMER SMELLED SMOKE WHEN TURNING ON THE MACHINE. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND FOUND A TRANSFORMER WITHIN THE GENERATOR CABINET APPEARED MELTED. THE GENERATOR CABINET AND CABLES TO THE TABLE WERE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803017 ↗
• MalfunctionSep 23, 2020Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A BIOPSY, AFTER THE CUSTOMER TOOK THE FIRST IMAGES, WHEN THE ARM WENT TO SWING TO DO THE SECOND IMAGE THE ENTIRE STAGE MOVED WITH IT. THE NEEDLE WAS IN THE PATIENT BREAST, BUT NO INJURY WAS REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE. IT WAS DETERMINED THAT THE STAGE ARM MOTOR NEEDED TO BE REPLACED, AND THE PIN, AND DETENT NEEDED TO BE CLEANED. ONCE THIS WAS COMPLETED, THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10573104 ↗
• MalfunctionFeb 25, 2020Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE BIOPSY ARM UNLOCKED DURING A BIOPSY PROCEDURE. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9750887 ↗
• MalfunctionFeb 7, 2020Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE STAGE ARM BRAKE WAS NOT WORKING. ADDITIONAL INFORMATION NOTED THAT DUE TO THIS ISSUE THE NEEDLE MOVED IN THE PATIENT BREAST. NO INJURY REPORTED. ADDITIONAL IMAGES WERE REQUIRED TO COMPLETE THE PROCEDURE RESULTING IN ADDITIONAL RADIATION. A FIELD ENGINEER WAS DISPATCHED TO THE SITE.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9683753 ↗
• MalfunctionSep 23, 2019Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE BIOPSY STAGE IS UNLOCKING WITH MINIMAL PRESSURE. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9105643 ↗
• MalfunctionJun 25, 2019Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A BIOPSY EXAM THE RADIOLOGIST BUMPED THE STAGE ARM AND THE ARM MOVED CAUSING THE NEEDLE TO MOVE WITHIN THE BREAST. NO INJURY REPORTED AND THE EXAM WAS ABLE TO BE FINISHED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THAT THE LOCK RING IN THE STAGE COMPRESSION ASSEMBLY NEEDED TO BE CLEANED. ONCE THIS WAS COMPLETED, THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8732543 ↗
• MalfunctionJun 4, 2019Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE C-ARM IS MOVING ON ITS OWN. REBOOTING THE SYSTEM DID NOT RESOLVE THE ISSUE. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND CYCLED THE LOCK ON THE C-ARM. ONCE THIS WAS COMPLETED, THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8667137 ↗
• MalfunctionMay 8, 2019Imprecision; Imprecision

  IT WAS REPORTED THAT "NEEDLE HIT ARRAY AND NOW CAUSING ARTIFACT." ADDITIONAL INFORMATION OBTAINED NOTED THAT DURING A BREAST BIOPSY WHEN THE NEEDLE FIRED AN ODD SOUND WAS HEARD AND THE PATIENT HAD SOME DISCOMFORT. THE PATIENT WAS NUMBED MORE AND THE BIOPSY WAS COMPLETED SUCCESSFULLY. NO MEDICAL INTERVENTION WAS NEEDED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8590336 ↗
• MalfunctionApr 8, 2019Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING QAS CALIBRATION THE TECHNOLOGIST WAS ABLE TO MOVE THE C-ARM FREELY. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8491932 ↗
• MalfunctionApr 5, 2019Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A PREVENTATIVE MAINTENANCE VISIT THE FIELD ENGINEER NOTED THE TABLE AND C-ARM TEND TO RANDOMLY MOVE UP WITHOUT ANYONE HITTING THE BUTTON. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8488081 ↗
• MalfunctionApr 3, 2019Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE TECHNOLOGISTS COULD NOT GET THE TABLE TO MOVE, THEN "PRESSED A BUNCH OF BUTTONS" AND THE TABLE DROPPED. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND IT WAS DETERMINED THE C-ARM MICRO SWITCHES WERE OUT OF ALIGNMENT. ONCE THE SWITCHES WERE ADJUSTED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8478440 ↗
• MalfunctionAug 15, 2018Unintended System Motion; Unintended System Motion

  THE FIELD ENGINEER WORKED WITH TECHNICAL SUPPORT AND IT WAS DETERMINED THAT THE DETENT BRACKET, DC MOTOR, AND SPRING 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 7784630 ↗
• MalfunctionMar 30, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE IT WAS NOTED THAT THE NEEDLE WAS MOVING AS THE C-ARM WAS MOVING. THERE WAS NO PATIENT INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND PER TECHNICAL SUPPORT THE VTA AND LOW VOLTAGE POWER SUPPLY WERE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS OPERATING AS INTENDED. THIS REPORT PERTAINS TO THE FIRST OF TWO EVENTS THAT OCCURRED WITH THIS SYSTEM. SEE ASSOCIATED MEDWATCH MANUFACTURERS REPORT # 1220984-2018-00091.

  Patient problems: Not Applicable

  MAUDE report 7384960 ↗
• MalfunctionMar 30, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE IT WAS NOTED THAT THE NEEDLE WAS MOVING AS THE C-ARM WAS MOVING. THERE WAS NO PATIENT INJURY REPORTED, BUT RETARGETING WAS NEEDED DUE TO THE NEEDLE MOVEMENT WHICH RESULTED IN THE PATIENT RECEIVING ADDITIONAL RADIATION. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND PER TECHNICAL SUPPORT THE VTA AND LOW VOLTAGE POWER SUPPLY WERE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS OPERATING AS INTENDED. THIS REPORT PERTAINS TO THE SECOND OF TWO EVENTS THAT OCCURRED WITH THIS SYSTEM. SEE ASSOCIATED MEDWATCH MANUFACTURERS REPORT # 1220984-2018-00092.

  Patient problems: Not Applicable

  MAUDE report 7384958 ↗
• MalfunctionDec 29, 2017Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THEY WERE GETTING GREY AND WASHED OUT IMAGES CAUSING THE PATIENT TO BE RE-EXPOSED. THEY REBOOTED THE SYSTEM AND WERE ABLE TO GET GOOD IMAGES. SINCE THE REBOOT OF THE SYSTEM THEY HAVE HAD NO PROBLEM.

  Patient problems: Not Applicable

  MAUDE report 7155131 ↗