ILLUMISITE ILS-1000-CS (UDI 10884521723634)Recalls & reported problems
Covidien LP · Console · Class 2
Quick summary
This Covidien Illumisite console is an x-ray-based computed tomography system. The 103 reports mostly describe software and connection problems, such as blank or error screens, disconnected location boards, and aborted procedures; 1 death and 75 injuries are described, including pneumothorax, hemorrhage and cardiac arrest. No recalls name this device. Reports fell from 20 in the prior 12 months to 4 in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 103
- Deaths reported
- 1
- Injuries reported
- 75
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 10884521723634), received between Jan 30, 2020 and Sep 15, 2026 — classified as 1 death, 75 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Application Program Problem” (50 reports).
1 other recall cover devices cleared under the same FDA submission (K191394); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Application Program Problem50
- Device Displays Incorrect Message37
- Adverse Event Without Identified Device or Use Problem29
- Patient Data Problem19
- Connection Problem11
- Application Network Problem9
- Communication or Transmission Problem7
- Device Sensing Problem7
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available45
- No Clinical Signs, Symptoms or Conditions30
- Pneumothorax19
- Insufficient Information7
- Hemorrhage/Blood Loss/Bleeding6
- Cardiac Arrest3
- No Code Available2
- Unintended Radiation Exposure2
Recent adverse event reports
The 25 most recent of 103 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Patient Data Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782311 ↗MalfunctionAug 14, 2026Patient Data Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50261793 ↗InjuryFeb 26, 2026Application Program Problem; Communication or Transmission Problem
IT WAS REPORTED THAT DURING A PROCEDURE, THE LOCATION BOARD (LB) WAS DISCONNECTED EVEN THOUGH IT WAS PLUGGED IN, WHICH RESULTED IN THE INABILITY TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE. THE CASE WAS NOT COMPLETED BY OTHER MEANS AND WAS ABORTED. REPLACEMENT OF THE CONTINUOUS GUIDANCE SYSTEM (CGS), LB, AND PATIENT SENSOR TRIPLET (PST) COMPONENTS WAS SUGGESTED, AND A NEW PIGTAIL HAS RECENTLY BEEN SENT OUT AND REPLACED BY THE SITE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24461874 ↗MalfunctionFeb 5, 2026Poor Quality Image; Device Displays Incorrect Message
IT WAS REPORTED THAT DURING THE MIDDLE OF A CASE, ALL SCREENS WERE MISSING EXCEPT FOR THE LOCAL REGISTRATION SCREEN, AND AN OUT OF SENSING VOLUME ERROR WAS OBSERVED WHILE THE PATIENT WAS UNDER ANESTHESIA. A RESTART OF THE INDUSTRIAL PERSONAL COMPUTER (IPC) WAS SUGGESTED AND PERFORMED, AFTER WHICH THE PHYSICIAN WAS ABLE TO BEGIN RE-REGISTERING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24272181 ↗InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, POST OPERATIVELY, PNEUMOTHORAX OCCURRED ON THE PATIENT AND WAS DISCOVERED ON ROUTINE POST-PROCEDURAL X-RAY. CHEST TUBE PLACEMENT WAS DONE AS PART OF THE INTERVENTION.
Patient problems: Pneumothorax
MAUDE report 23344365 ↗InjurySep 11, 2025Break; Application Program Problem; Communication or Transmission Problem; Break; Application Program Problem; Communication or Transmission Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, THE PORT THAT HAS THE CABLE THAT CONNECTS TO THE LOCATION BOARD WAS DAMAGED. THE CASE WAS CANCELLED DUE TO INABILITY TO CONNECT THE LOCATION BOARD (LB). THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION WAS NOT COMPLETED AND NOT COMPLETED BY OTHER MEANS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23025487 ↗InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN MARCH 2019 TO FEBRUARY 2024, A RETROSPECTIVE STUDY ANALYZED THE HYBRID TREATMENT OF MULTIFOCAL LUNG MALIGNANCY BY CONCOMITANT TRANSBRONCHIAL MICROWAVE ABLATION WITH SAME-SESSION LUNG RESECTION AND POST-LUNG RESECTION ABLATION WITH CONCOMITANT VIDEO-ASSISTED THORACOSCOPIC LUNG RESECTION. A TOTAL OF 92 PATIENTS WERE INCLUDED IN THE STUDY. THERE WERE 103 PROCEDURES PERFORMED AND 162 LUNG NODULES TREATED 142 LUNG NODULES WERE ABLATED AND 20 LUNG NODULES WERE RESECTED. 6 PATIENTS HAD COMPLICATIONS 1) PERSISTED FEVER, (2) AIRWAY BLEEDING, (2) PNEUMOTHORAX AND (1) BRONCHOPLEURAL FISTULA. ORAL ANTIBIOTICS WERE GIVEN, CHEST TUBE DRAINAGE WAS DONE AND ENDOBRONCHIAL VALVE PLACEMENT ON. RE-ADMISSION WAS REQUIRED. HYBRID TREATMENT OF MULTIFOCAL LUNG MALIGNANCY BY CONCOMITANT TRANSBRONCHIAL MICROWAVE ABLATION WITH SAME-SESSION LUNG RESECTION AND POST-LUNG RESECTION ABLATION. DR. CALVIN NG, 2025, INTERDISCIPLINARY CARDIOVASCULAR AND THORACIC SURGERY.
Patient problems: Fever; Fistula; Pneumothorax
MAUDE report 22926527 ↗MalfunctionAug 25, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down
IT WAS REPORTED THAT DURING THE PROCEDURE, THE MONITOR WENT DARK AND THE SYSTEM SHUT OFF, BUT SUBSEQUENTLY CAME BACK ON AND REQUIRED RE-REGISTRATION. THE PATIENT WAS UNDER ANESTHESIA AT THE TIME. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22891091 ↗MalfunctionJul 25, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down
IT WAS REPORTED THAT DURING THE PROCEDURE, THE ILLUMISITE SYSTEM WENT BLACK DURING THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22616746 ↗MalfunctionJul 21, 2025Failure to Advance; Device Displays Incorrect Message; Failure to Advance; Device Displays Incorrect Message
IT WAS REPORTED THAT DURING A PROCEDURE, WHEN A PHYSICIAN WENT TO PERFORM AUTOMATIC REGISTRATION, THE FIRST CATHETER WENT BETWEEN THE ERROR MESSAGES OF THE NAVIGATION CATHETER OUT OF SENSING VOLUME AND NOT COUPLED. THE SURGEON REPLACED THE CABLES AND THE PATIENT'S POSITION WAS CHECKED, BUT THE SAME ISSUE OCCURRED. ANOTHER CATHETER WAS THEN USED. LATER IN THE PROCEDURE, AFTER NAVIGATION AND BIOPSIES, THE CATHETER WAS NOT COUPLING, EVENTUALLY, AN ERROR OF REPLACED LOCATABLE GUIDE (LG) APPEARED. ADDITIONALLY, THE CATHETER WAS BROKEN. THE CATHETER WAS REPLACED AGAIN, RESOLVING THE ISSUE. THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22561557 ↗MalfunctionJul 3, 2025Computer Software Problem; Erratic or Intermittent Display; Device Displays Incorrect Message; Computer Software Problem; Erratic or Intermittent Display; Device Displays Incorrect Message
IT WAS REPORTED THAT DURING A PROCEDURE, OUTSIDE OF MAGNETIC VOLUME ERRORS WERE OBSERVED DURING REGISTRATION, ALTHOUGH REGISTRATION APPEARED NORMAL AND THE PROCEDURE WAS ABLE TO PROCEED MOSTLY AS USUAL. DURING BRUSH PASSES, THE SCREEN COMPLETELY FROZE. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22401124 ↗InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOLLOWING A PROCEDURE USING THE CONSOLE, A PATIENT WITH A MEDICAL HISTORY OF A LUNG NODULE EXPERIENCED A PNEUMOTHORAX, WHICH WAS DISCOVERED ON A ROUTINE POST-OPERATIVE X-RAY. THE PNEUMOTHORAX RESULTED IN REQUIRING A CHEST TUBE PLACEMENT AS TREATMENT. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED.
Patient problems: Pneumothorax; Unintended Radiation Exposure
MAUDE report 22248066 ↗InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON WENT AFTER THE RIGHT UPPER LOBE (RUL) IN THE VERY PROXIMAL POSTERIOR SEGMENT. THE USER DID THE NAVIGATION, THE NEEDLES PASSED AND THE FORCEPS BITE WITH NO ISSUES. A BIOPSY SYSTEM FROM ANOTHER MANUFACTURER WAS USED AT THE END OF THE CASE. THE SURGEON AND FELLOW DID THE PASSES USING THAT SYSTEM. THE SURGEON GRABBED PART OF THE PULMONARY ARTERY, AND A MASSIVE AIRWAY BLEED WAS DISCOVERED WHEN PERFORMING A BRONCHOALVEOLAR LAVAGE (BAL). THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE EVENT LED TO AN EXTENSION OF THE PATIENT'S HOSPITALIZATION AND RESULTED IN A TEMPORARY INJURY.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21926270 ↗InjuryApr 3, 2025Application Program Problem; Patient Data Problem; Application Program Problem; Patient Data Problem
IT WAS REPORTED THAT DURING A PROCEDURE, THE AUTOMATIC REGISTRATION WOULD NOT BE COMPLETED. THE PHYSICIAN ATTEMPTED TO COMPLETE THE AUTOMATIC REGISTRATION WITHOUT SUCCESS, TRYING DIFFERENT CATHETERS AND CABLES, REBOOTING THE SYSTEM, AND REPLANNING THE PROCEDURE, BUT NONE OF THESE TROUBLESHOOTING STEPS WERE SUCCESSFUL. GENERAL ANESTHESIA WAS USED, AND THE PROCEDURE WAS ABORTED, BEING UNABLE TO DIAGNOSE THE PATIENT. IT WAS NOTED THAT UPON REPLACEMENT OF ALL CABLES, THE SYSTEM WAS FUNCTIONING PROPERLY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21767493 ↗InjuryApr 3, 2025Device Displays Incorrect Message; Application Program Problem; Device Displays Incorrect Message; Application Program Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, OUT OF SENSING VOLUME ERROR OCCURRED DURING REGISTRATION, LEADING TO THE REGISTRATION POINTS BEING MISALIGNED TO THE RIGHT OF THE 3D TREE. AS A RESULT, THE PHYSICIAN WAS UNABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE, AND THE PROCEDURE WAS ABORTED WHILE THE PATIENT WAS UNDER ANESTHESIA. IT WAS MENTIONED THAT THE PROCEDURE WAS RESCHEDULE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21766840 ↗InjuryMar 26, 2025Application Program Problem; Adverse Event Without Identified Device or Use Problem; Patient Data Problem; Application Program Problem; Adverse Event Without Identified Device or Use Problem; Patient Data Problem
IT WAS REPORTED THAT DURING A PROCEDURE, A MAJOR AIRWAY BLEED OF UNSPECIFIED AMOUNT OCCURRED DURING FINAL AUTOMATIC REGISTRATION. A STENT WAS USED TO RESOLVE THE ISSUE. THE PHYSICIAN WAS UNABLE TO COMPLETE THE SUPER DIMENSION PORTION OF THE CASE, AND THE ENTIRE NAVIGATION HAD TO BE ABORTED TO STABILIZE THE PATIENT. THE PHYSICIAN WAS USING A NAVIGATION CATHETER WHEN THE BLEED BEGAN. THE PROCEDURE WAS EXTENDED FOR MORE THAN 30 MINUTES AND WAS COMPLETED BY OTHER MEANS. THE PATIENT HAD TO STAY OVERNIGHT AND WAS ABLE TO LEAVE THE NEXT DAY.
Patient problems: Bronchial Hemorrhage
MAUDE report 21703999 ↗MalfunctionMar 11, 2025Use of Device Problem; Application Network Problem; Activation, Positioning or Separation Problem; Unintended Application Program Shut Down; Use of Device Problem; Application Network Problem; Activation, Positioning or Separation Problem; Unintended Application Program Shut Down
IT WAS REPORTED THAT PREOPERATIVELY, THERE WAS AN ISSUE WITHIN STARTUP OF THE UNIT WHEN IT SHUT DOWN UNEXPECTEDLY AND HAD TO BE REBOOTED. A SYSTEM CHECK FOR THE ILLUMISITE WAS REQUESTED DUE TO CONCERNS FROM END USERS. THERE WAS NO PATIENT INVOLVED. UPON SERVICING, THREE ISSUES WERE IDENTIFIED. FIRST ISSUE WAS A USER INTERFACE SCREEN POP-UP WINDOW DIFFERENCE THE ACCOUNT WERE NOT FAMILIAR WITH. ONE OF THE USER VOLUNTEERED TO BE THE PATIENT ON THE TABLE AND THE OTHER ONE AS THE CLINICIAN, WHILE THE FIELD SERVICE ENGINEER (FSE) OBSERVED, UPON ATTACHING LEADS IT WAS DISCOVERED THAT PLACEMENT AND THE ADHERING OF THE TAPE ON CLOTHES MADE THE TAPE NOT STICK WELL. UPON THE LEAD DETACHING INTERMITTENTLY, THE POP-UP WINDOW DIFFERENCE APPEARED. AFTER TROUBLESHOOTING AND DISCUSSING THE PREVIOUS PATIENT, IT WAS SUSPECTED THE ELASTICITY OF SAID PATIENT COULD HAVE CAUSED THIS ISSUE TO OCCUR. THE REMAINING TWO ISSUES WAS THE TRACKBALL AND THE LOCATER BOARD CABLE ASSEMBLY ALIGNMENT. THE FSE WAS ABLE TO CLEAN THE OPTICS WITHIN THE TRACKBALL ASSEMBLY WHICH WAS FULLY COVERED BY RESIDUE. ONCE CLEANED THROUGHOUT TRACKBALL WAS OPERATIONAL. THE LOCATER BOARD CABLING NEEDED TO BE RETIGHTENED AND REALIGNED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21578280 ↗MalfunctionFeb 26, 2025Device Displays Incorrect Message; Application Program Problem; Device Sensing Problem; Device Displays Incorrect Message; Application Program Problem; Device Sensing Problem
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SUPERDIMENSION SYSTEM, AN INVALID NAVIGATION CATHETER MOVEMENT ERROR OCCURRED. INITIALLY, THE PATIENT SENSOR TRIPLET (PST) WAS NOT VISIBLE IN THE SOFTWARE, PROMPTING THE CABLE TO BE UNPLUGGED AND RECONNECTED. THE PST WAS THEN SEEN, BUT REMAINED OUT OF THE SENSING VOLUME, NECESSITATING MULTIPLE ADJUSTMENTS TO THE PATIENT'S POSITION. THE PHYSICIAN WAS UNABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE. THE PROCEDURE WAS ULTIMATELY COMPLETED USING ENDOBRONCHIAL ULTRASOUND (EBUS) WHILE THE PATIENT WAS UNDER ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. UPON SERVICING, PERFORMED ACCURACY CHECKOUT PROCEDURE AND FLOURO CHECKOUT PROCEDURE. ACCURACY CHECKOUT AND FLOURO PROCEDURE PASSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21470899 ↗InjuryJan 24, 2025Computer Software Problem; Display or Visual Feedback Problem; Application Program Problem; Computer Software Problem; Display or Visual Feedback Problem; Application Program Problem
ACCORDING TO THE REPORTER, DURING AN ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB), THE BRONCH VIDEO WAS NOT SENSED AND THEN THE APPLICATION WON'T START. THE PATIENT WAS UNDER SEDATION AND THE CASE WAS CANCELLED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 21228911 ↗MalfunctionJan 22, 2025Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE HAD AN ERROR MESSAGE THAT THE NAVIGATION CATHETER WAS OUT OF SENSING VOLUME. THE PATIENT WAS UNDER ANESTHESIA, AND THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE. THERE WERE NO PATIENT COMPLICATIONS OR HARMS AS A RESULT OF THE ISSUE. A SITE VISIT WAS REQUESTED FOR FURTHER ASSESSMENT. UPON SERVICING, AN ACCURACY CHECK WAS REQUESTED, AND IT WAS COMPLETED AND PASSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21211105 ↗InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A PROCEDURE, A BIOPSY OF A VASCULAR NODULE IN THE UPPER LEFT LOBE WAS DONE, EXCESSIVE BLEEDING OCCURRED AFTER, LEADING TO A MYOCARDIAL INFARCTION. THE PATIENT WAS SUBSEQUENTLY BROUGHT TO THE INTENSIVE CARE UNIT (ICU) FOR RECOVERY AND OBSERVATION, EXTENDING HOSPITALIZATION BY ONE DAY.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Myocardial Infarction
MAUDE report 21112536 ↗MalfunctionDec 27, 2024Device Displays Incorrect Message; Device Displays Incorrect Message
ACCORDING TO THE REPORTER, DURING A ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB), THE LOCATABLE GUIDE WAS COMING OUT OF SENSING VOLUME WHILE THE EXTENDED WORKING CHANNEL WAS STAYING IN. THE LESION WAS IN THE ANTERIOR MID/LUNG. IT WAS SUGGESTED TO RAISE THE PATIENT UP HOWEVER THEY WERE UNABLE TO COMPLETE THIS STEP. RE-REGISTERING AND MOVING THE PATIENT SENSOR TRIPLET DID NOT RESOLVE THE ISSUE. THE SUPER DIMENSION PORTION OF THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21028157 ↗InjuryNov 27, 2024Unintended Application Program Shut Down; Unintended Application Program Shut Down
ACCORDING TO THE REPORTER, DURING A ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) IN THE MIDDLE OF THE PROCEDURE, THE INTRAPERSONAL COMPUTER TURNED OFF. A FULL SYSTEM REBOOT WAS PERFORMED WHICH DID NOT RESOLVE THE ISSUE. THEY THEN TOOK POWER FROM THE UNINTERRUPTABLE POWER SUPPLY FROM THE WALL OUTLET AND ATTEMPTED TO MANUALLY TURN ON THE DEVICE TO NO AVAIL. THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE BUT THE CASE WAS ABORTED. IT WAS NOTED THAT THE PATIENT WAS UNDER ANESTHESIA.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20801267 ↗InjuryNov 11, 2024Device Displays Incorrect Message; Application Network Problem; Application Program Problem; Device Displays Incorrect Message; Application Network Problem; Application Program Problem
ACCORDING TO THE REPORTER, DURING AN ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) PROCEDURE, THE SOFTWARE WAS SHOWING THAT THEY WERE ON THE LOWER LOBE, WHILE FLUOROSCOPIC IMAGING SHOWED THEM IN THE UPPER LOBE. IT WAS ALSO REPORTED THAT THE DEVICE WAS SHOWING AS O UTSIDE OF THE SENSOR SENSING VOLUME.
Patient problems: Insufficient Information
MAUDE report 20651947 ↗MalfunctionOct 21, 2024Application Network Problem; Patient Data Problem; Application Network Problem; Patient Data Problem
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THERE WAS DIFFICULTY OBTAINING SUCCESSFUL AUTOMATIC REGISTRATION. THE SURGEON STATED THAT THE LOCATABLE GUIDE CALIBRATION WAS OFF BY ABOUT TWO CENTIMETERS SINCE LAST PREVENTATIVE MAINTENANCE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 20494445 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K191394. One submission often covers many models, so check the product and lot details in each record.
- Z-2008-2023 · May 22, 2023 · Open, ClassifiedMedtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
Other System, x-ray, tomography, computed devices
- ARTIS icono biplane 11327600Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls2 deaths55 reports
- ARTIS icono floor 11327700Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls24 reports
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, x-ray, tomography, computed13 recalls5 reports
- Spectral CTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed11 recalls3 reports
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, X-Ray, Tomography, Computed9 recalls20 reports
- Brilliance iCTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed8 recalls6 reports
- Revolution Apex EliteGE Medical Systems, L.L.C. · System, x-ray, tomography, computed8 recalls0 reports
- Brilliance CT Big BorePhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed7 recalls1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.