O-armTM O2 Imaging System BI70002000Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00763000709631), received between Oct 31, 2024 and Sep 8, 2026 — classified as 1 death, 71 malfunctions.

The most frequently reported specific device problem is “Image Display Error/Artifact” (21 reports).

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

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. May 19, 2026Class IIOpen, Classified

   Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.

   Z-2451-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 27, 2025Class IIOpen, Classified

   A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.

   Z-2101-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Device Damaged Prior to Receipt by User; Arcing; Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672754 ↗
• MalfunctionMay 29, 2026Image Display Error/Artifact; Calibration Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING SURGERY, THE INITIAL SCAN WAS UNUSABLE DUE TO A LARGE RING ARTIFACT AND SOME SCATTER. SITE REBOOTED THE SYSTEM AND WAS ABLE TO RESOLVE THE ISSUE WITH THE 2ND SCAN. MANUFACTURING REPRESENTATIVE (REP) DID MENTIONED THAT THE SYSTEM MIGHT HAVE BEEN OVERDUE ON CALIBRATION, BUT THE SITE WAS EXPECTED TO PERFORM CALIBRATION SOON. THIS ISSUE OCCURRED INTRAOPERATIVELY AND CAUSED LESS THAN 1 HOUR SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333082 ↗
• MalfunctionMay 29, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN SITE PERFORMED A SCOUT IN AP/LATERAL UNDER 2D, A BLACK LONG BAR APPEARED IN THE AP/LATERAL. THEY THEN PERFORMED A 3D WITH SMARTDOSE AND A CIRCLE APPEARED IN THE SCAN. THEY ALSO TRIED 3D UNDER HD AND GOT SAME RESULTS. ALSO REPORTED DOING A TEST SPIN AFTER CASE WITHOUT A PATIENT WITH THE SAME RESULTS AND IT'S UNDER PATIENT NAME: TEST, TEST. THIS ISSUE OCCURRED INTRA OPERATIVELY AND CAUSED LESS THAN 1 HOUR SURGICAL DELAY. THERE WAS NO REPORTED IMPACT TO THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330474 ↗
• MalfunctionMay 29, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS A BLACK LINE WHEN THEY DID THE IMAGES. WHEN IT WAS SENT OVER TO THE NAVIGATION SYSTEM THE LINES WERE STILL THERE. THIS ISSUE OCCURRED INTRAOPERATIVELY AND CAUSED LESS THAN 1 HOUR SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. TROUBLESHOOTING SATING THAT TECHNICAL SERVICE (TS) SUGGESTED TO REDO CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330329 ↗
• MalfunctionMay 29, 2026Image Display Error/Artifact; Calibration Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT WHEN TAKING A SCAN, ARTIFACTS WERE APPEARING ON THE IMAGE. SITE ATTEMPTED MULTIPLE SCANS. REPRESENTATIVE RECOMMENDED TO SITE THAT RAD CALIBRATION BE PERFORMED. PATIENT WAS PRESENT. THERE WAS UNKNOWN SURGICAL DELAY AND IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE REPORTED ISSUE CAUSED A 20 MINUTE DELAY TO THE CASE. THERE WAS NO REPORTED IMPACT.DDITIONAL INFORMATION RECEIVED "MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED L3-4-5 FUSION AND TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF).ADDITIONAL INFORMATION RECEIVED AS "ISSUE OCCURRED PERIOPERATIVELY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25327216 ↗
• MalfunctionMay 28, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING A PROCEDURE, IMAGES OBTAINED WITH THE IMAGING SYSTEM DISPLAYED A LARGE BLACK BAR THROUGH THE MIDDLE. THE ISSUE OCCURRED INTRAOPERATIVELY. AFTER REBOOTING THE SYSTEM AND ACQUIRING NEW IMAGES, THE BLACK BAR WAS NO LONGER PRESENT, AND NO FURTHER ISSUES WERE NOTED. THERE WAS LESS THAN AN HOUR DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT. THIS CASE CAN BE CLOSED. FSE WAS ABLE TO ACCESS THE MACHINE AND COULD NOT REPRODUCE THE ISSUE WITNESSED. PERFORMED 4 ROUNDS OF GAIN CALS AND REBOOTED THE UNIT MULTIPLE TIMES. CURRENTLY THE IMAGE QUALITY IS WELL WITHIN SPEC. FSE WAS TOLD BY FACTORY SUPPORT THE ISSUE CAPTURED IN THE PHOTOS IS KNOWN AND A SOLUTION IS CURRENTLY IN THE WORKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25315738 ↗
• MalfunctionMay 27, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT SYSTEM HAD AN IMAGE ARTIFACT WITH BARS. A REBOOT RESOLVED THIS. THIS ISSUE OCCURRED INTRA OPERATIVELY AND CAUSED NO SURGICAL DELAY. THERE WAS NO REPORTED IMPACT TO THE PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED THAT IT WAS AN ASIC(APPLICATION-SPECIFIC INTEGRATED CIRCUIT) ISSUE WITH VARIAN AND THE DETECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300592 ↗
• MalfunctionMay 27, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING A IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT IMAGE ARTIFACTS WHEN TAKING A 3D SPIN. PATIENT WAS PRESENT. THERE WAS NO SURGICAL DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299604 ↗
• MalfunctionMay 27, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT A BLACK BAR WAS SHOWING UP ON THE SCREEN DURING FLOURO (IMAGE ARTIFACTS). WHEN SPINNING THE SECTION OF "DEAD PIXELS" TURNED INTO A "WHITE RING" IN THE 3D SPIN. ARTIFACT CARIED OVER TO NAVIGATION SYSTEM. PATIENT WAS PRESENT. THERE WAS NO SURGICAL DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299490 ↗
• MalfunctionMay 27, 2026Image Display Error/Artifact; Poor Quality Image

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT POOR IMAGE QUALITY AFTER TAKING A 2D IMAGE. THERE WERE TWO BLACK BARS RUNNING THROUGH IT. THE 3D IMAGE HAD A CIRCLE THROUGH THE IMAGE. THE SITE PROCEEDED WITH ANOTHER IMAGING SYSTEM. PATIENT WAS PRESENT. THERE WAS LESS THAN ONE HOUR OF SURGICAL DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25298541 ↗
• MalfunctionMay 26, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT REPORT LINES ON 2D AND 3D IMAGES. CLINICAL CONSULTANT REPORTED TWO VERTICAL WHITE LINES ON THE SAGITTAL AND CORONAL VIEWS, AND A WHITE RING AROUND THE AXIAL IMAGE. THE 2D IMAGE HAD ONE BLACK LINE ON THE SIDE OF THE IMAGE. LINES DO NOT OBSTRUCT THE VIEW OF THE ANATOMY, SO THEY WERE USED DURING THE CASE. THIS WAS OCCURRED INTRA OPERATIVELY. THERE WAS A REPORTED NO DELAY AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25278057 ↗
• MalfunctionMay 26, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT A CYLINDER RING ARTIFACT APPEARED AGAIN AFTER AN IMAGING SYSTEM SPIN. THIS WAS THE SECOND INCIDENT SINCE FEB 2. ANOTHER IMAGING SYSTEM WAS BROUGHT IN FOR ANOTHER 3D SPIN THIS WAS OCCURRED INTRA OPERATIVELY. THERE WAS LESS THAN 1 HOUR DELAY AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25277833 ↗
• MalfunctionMay 26, 2026Mechanical Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT A "DEAD" ASIC DURING A CASE. REPRESENTATIVE REPORTED THAT A BLACK BAR SHOWS UP ON THE DETECTOR. SITE REBOOTED THE SYSTEM AND THE ISSUE WAS RESOLVED. CAUSED LESS THAN 1 HOUR SURGICAL DELAY AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25277218 ↗
• MalfunctionMay 26, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING A CASE, AN ARTIFACT WAS ON THEIR SCANS (INCLUDING THE 3D SCAN). CS REPORTED IT WAS THE SAME ARTIFACT THAT APPEARED UNDER DIFFERENT CASE. SITE CONTINUED WITH CASE BY USING THE OTHER IMAGING SYSTEM ONSITE. THIS ISSUE OCCURRED INTRAOPERATIVELY, AND THERE WAS LESS THAN ONE HOUR DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT INVOLVED. ADDITIONAL INFORMATION UPDATED. CLINICAL SERVICE SPOKE WITH THE TECHS AT THE SITE. SINCE THIS HAD HAPPENED BEFORE THEY REBOOTED THE MACHINE AND TRIED ON ANOTHER PATIENT. THE ARTICLE HAS NOT BEEN SEEN IN THE SUBSEQUENT IMAGES AND SPINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273638 ↗
• MalfunctionMay 26, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN TAKING A 3D SPIN OF THE PATIENT, THE SITE SAW A BIG BLACK RECTANGULAR ARTIFACT IN THE MIDDLE OF THE EXAM. THEY HAD REBOOTED THE SYSTEM WHICH RESOLVED THE ISSUE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF 1 HOUR OR LONGER DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273576 ↗
• MalfunctionMay 23, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT A CIRCULAR ARTIFACT ON IMAGES. A FEW 2D IMAGES WERE TAKEN, WITH THE ARTIFACT APPEARING. A 3D IMAGE WAS TAKEN AFTER AND NO ARTIFACT WAS PRESENT. NO PATIENT DEMOGRAPHICS WERE AVAILABLE AT TIME OF CALL. THERE WAS UNKNOWN DELAY TO THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED. ARTIFACT ISSUE WAS RESOLVED WITH A SYSTEM REBOOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25264279 ↗
• MalfunctionMay 23, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE IMAGES ON MOBILE VIEW STATION (MVS) HAD TWO LINES OF ARTIFACT. THIS ISSUE OCCURRED INTRAOPERATIVELY, AND THERE WAS LESS THAN ONE HOUR DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25264248 ↗
• MalfunctionMay 22, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT AN IMAGE ARTIFACT ON 3D IMAGES. THEY USED ANOTHER IMAGING SYSTEM TO PROCEED WITH THE CASE. THIS ISSUE OCCURRED INTRA OPERATIVELY. THERE WAS NO REPORTED IMPACT TO THE PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED "DELAY CAUSED ABOUT 10 MINS BY SWAPPING IT OUT WITH THE OTHER IMAGING SYSTEM ON SITE AND CASE WENT WELL AFTER THAT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25252087 ↗
• MalfunctionMay 22, 2026Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE WAS UNABLE TO OPEN, CLOSE, OR DOCK THE GANTRY. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25251245 ↗
• MalfunctionMay 21, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS STILL IMAGE ARTIFACT EVEN THOUGH THE SYSTEM HAD BEEN CALIBRATED. IT OCCURRED INTRA OPERATIVELY AND THERE WAS NO DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241073 ↗
• MalfunctionMay 21, 2026Image Display Error/Artifact; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A PROCEDURE. IT WAS REPORTED REGARDING DETECTOR ASIC ISSUE THAT A BLACK RECTANGLE SHOWS ON EVERY IMAGE DURING EXPOSURE. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241068 ↗
• MalfunctionMay 21, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SYSTEM PRODUCED AN ARTIFACT IN BOTH 2D SHOTS AND IN THE 3D SPIN. PATIENT WAS PRESENT. THERE WAS UNKNOWN SURGICAL DELAY AND IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED "SPINE FUSION PROCEDURE INVOLVED. THERE WAS LESS THAN 10 MINS OF DELAY. ISSUE OCCURRED INTRA-OPERATIVELY. THERE WAS NO IMPACT ON PATIENT OUTCOME".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240104 ↗
• MalfunctionMay 20, 2026Image Display Error/Artifact

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE IMAGING SYSTEM PRODUCED A CYLINDRICAL ARTIFACT WHEN A 3D SPIN WAS TAKEN. THIS ARTIFACT DID NOT APPEAR WHEN THE SITE TOOK 2D SHOTS. SITE ABANDONED USE OF THIS AND ANOTHER IMAGING SYSTEM WAS BROUGHT IN TO COMPLETE SURGERY AND THE PATIENT WAS EXPOSED A SECOND TIME. THIS ISSUE OCCURRED INTRA OPERATIVELY AND CAUSED LESS THAN 1 HOUR SURGICAL DELAY. THERE WAS NO REPORTED IMPACT TO THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25227713 ↗
• MalfunctionMar 12, 2026Mechanical Problem; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED REGARDING DOOR STUCK CLOSED THAT WHEN REPRESENTATIVE WAS CLOSING THE GANTRY DOOR FOR CONFIRMATION SPIN, THE DRAPING AS GETTING CAUGHT IN THE DOOR. REPRESENTATIVE FIXED DRAPE AND CLOSED DOOR SUCCESSFULLY. AFTER TAKING SPIN, HE COULD NOT OPEN DOOR WITH EMERGENCY BUTTON, SO HE HAD TO MANUALLY CRANK IT OPEN. AFTER REMOVING SYSTEM FROM ROOM, HE VERIFIED THAT THE DOOR WOULD OPEN AND CLOSE SEVERAL TIMES WITHOUT ISSUE. REPRESENTATIVE WANTS TO GET SYSTEM CHECKED OUT TO ENSURE PROPER ALIGNMENT OF INTERNAL COMPONENTS. THIS ISSUE OCCURRED POSTOPERATIVELY AND CAUSED LESS THAN 1 HOUR SURGICAL DELAY. THERE WAS NO REPORTED IMPACT TO THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581450 ↗
• MalfunctionFeb 9, 2026Application Program Problem; Calibration Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT WHEN ATTEMPTING TO TAKE A SPIN, AN ERROR MESSAGE POPULATED STATING THAT STATED "IMAGE FRAME RATES ARE UNDER RECOMMENDED LEVELS". ALSO, REPORTED THAT THEY REBOOTED THE SYSTEM AND UPON BOOT UP, IT WAS DISPLAYING THAT THE MOTION CALIBRATION WAS NEEDED. THIS ISSUE OCCURRED INTRAOPERATIVELY AND CAUSED UNKNOWN SURGICAL DELAY. UPON TROUBLESHOOTING, REBOOTED THE SYSTEM WITH AND WITHOUT THE UMBILICAL CORD CONNECTED AND EACH TIME THE MOTION CALIBRATION MESSAGE DISPLAYED. SYSTEM WAS AROUND PATIENT. MEDTRONIC REPRESENTATIVE PRESSED THE OPEN GANTRY BUTTON AND REPORTED THAT THE GANTRY STARTED TO "TILT" AS IT WAS PERFORMING THE CALIBRATION SO, ATTEMPTED USING THE YELLOW BUTTON AND BUTTON ON PENDANT TO OPEN THE GANTRY DOORS BUT THE GANTRY STARTED TO TILT AGAIN. MANUALLY OPENED THE GANTRY TO REMOVE IT FROM AROUND THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289188 ↗