INTERVENTIONAL ANGIOGRAPHY SYSTEMRecalls & reported problems across all models

We found 3 models of INTERVENTIONAL ANGIOGRAPHY SYSTEM by Canon Inc. in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2024 and May 14, 2026 — classified as 1 death, 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Inadequate User Interface” (1 report).

5 FDA recall records name at least one of these models by its device identifier, 5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

INTERVENTIONAL ANGIOGRAPHY SYSTEM recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 26, 2026Open, Classified

   Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error

   Z-0108-2027 · Root cause: Process control · Recall details · FDA record ↗

2. Nov 15, 2023Open, Classified

   VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.

   Z-1155-2024 · Root cause: Component change control · Recall details · FDA record ↗

3. Nov 15, 2023Open, Classified

   VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.

   Z-1154-2024 · Root cause: Component change control · Recall details · FDA record ↗

4. Jun 22, 2023Open, Classified

   The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue using the operators console, the switches on the back of the column, switches on the side of the flat panel detector, and the emergency stop will continue to function normally.

   Z-2392-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

5. May 3, 2022Open, Classified

   CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated.

   Z-1289-2022 · Root cause: Software design · Recall details · FDA record ↗

Most reported INTERVENTIONAL ANGIOGRAPHY SYSTEM problems

INTERVENTIONAL ANGIOGRAPHY SYSTEM models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• INTERVENTIONAL ANGIOGRAPHY SYSTEM INFX-8000C

  System, x-ray, fluoroscopic, image-intensified
  4 recalls3 reports
• INTERVENTIONAL ANGIOGRAPHY SYSTEM INFX-8000F

  Solid state x-ray imager (flat panel/digital imager)
  1 recall0 reports
• INTERVENTIONAL ANGIOGRAPHY SYSTEM INFX-8000V

  Interventional fluoroscopic x-ray system
  1 death3 reports

Recent INTERVENTIONAL ANGIOGRAPHY SYSTEM adverse event reports

The 6 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026 DURING THE TRANSFER FROM THE HOSPITAL BED / GURNEY TO THE PROCEDURE TABLE A PATIENT BECAME UNSTABLE WHILE BEING MOVED TO THE PROCEDURE TABLE AND SLIPPED. HOSPITAL STAFF CAUGHT THE PATIENT BEFORE HE HIT THE FLOOR AND THE PATIENT RECEIVED NO INJUIRES AS A RESULT OF THIS INCIDENT.

  Patient problems: Insufficient Information

  MAUDE report 25166893 ↗
• MalfunctionApr 2, 2026Material Fragmentation

  DURING AUTOMATIC POSITIONING, THE C-ARM AND OMEGA CONTACTED. AFTER THAT, A USER ATTEMPTED TO KEEP THE ARMS SEPARATED BUT OPERATED AS THE ARMS WERE FURTHER STRONGLY CONTACTED BY ADDITIONAL USER OPERATIONS. THIS CAUSED DAMAGE TO THE X-RAY BEAM LIMITING DEVICE UNIT AND THE OCCURRENCE OF AN ERROR OF THIS UNIT. AFTER THE STUDY WAS FINISHED, A CUSTOMER ENGINEER FOUND THAT THE ROTATION MECHANISM CAME OFF. THERE WAS NO HARM TO THE PATIENT OR USER, NOR ANY DAMAGE TO SURROUNDING EQUIPMENT. THIS EVENT DID NOT AFFECT THE STUDY BECAUSE THIS HAPPENED AT THE END OF THE STUDY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772377 ↗
• InjuryMar 13, 2026Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2026, AT A (B)(6) HOSPITAL DURING AN EXAMINATION THE DOCTOR TRIED TO MOVE AROUND WHILE AVOIDING A LARGE MONITOR WHICH WAS ON THE CEILING SUSPENSION STAND. HOWEVER, HE STOOD UP BEFORE HE COULD COMPLETELY AVOID THE MONITOR, CAUSING THE TOP OF THE DOCTOR'S HEAD TO COLLIDE WITH THE CORNER OF THE MONITOR. THIS RESULTED IN A LACERATION ON THE TOP RIGHT SIDE OF THE DOCTOR'S HEAD, THAT REQUIRED STITCHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594951 ↗
• MalfunctionDec 17, 2025Unexpected Mode Switch; Unexpected Mode Switch

  DURING USE OF STENT ENHANCE ON (B)(6) 2025 THE SYSTEM LOCKED UP. AFTER SYSTEM LOCK UP, STAFF FORCED SHUTDOWN AND WAS ABLE TO REBOOT ONLY AFTER MULTIPLE ATTEMPTS. DURING THIS TIME, TOTALING MORE THAN 30 MINUTES STAFF WERE UNABLE TO PERFORM FLUORO OR DA AND PATIENT WENT INTO CARDIAC ARREST. AFTER SYSTEM REBOOT THE SYSTEM OPERATED NORMALLY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Cardiac Arrest

  MAUDE report 23832810 ↗
• MalfunctionFeb 12, 2025Unintended Movement; Unintended Movement

  ON JANUARY 15TH AT A JAPANESE HOSPITAL AFTER THE C-ARM WAS MOVED TO THE PARK POSITION, THE C-ARM MOVED DUE TO USER OPERATION ERROR. AFTER COLLIDING WITH THE SHELF, AN ERROR MESSAGE WAS DISPLAYED AND THE C-ARM STOPPED. THE SHELF WAS SLIGHTLY DAMAGED, BUT THERE WAS NO HARM TO THE PATIENT OR STAFF. INVESTIGATION DETERMINED THEIR WAS NO ISSUE WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368490 ↗
• DeathJun 13, 2024Inadequate User Interface; Inadequate User Interface

  IN A HOSPITAL, LOCATED IN SPAIN, ON (B)(6) 2024 IT WAS ALLEGED BY THE USER THAT "IMAGE DEFINITION IS LOST WHEN MAGNIFYING, THIS PREVENTS THE CORRECT VISUALIZATION OF THE CATHETER NAVIGATION USING FLUORO AND ALSO PREVENTS THE CORRECT RELEASE OF THE STENTS OR FLOW DIVERTER DEVICES. ALSO, THE GRAIN OF THE IMAGE AND THE HALO EFFECT AROUND THE COILS ARE PRONOUNCED". THE PATIENT FROM (B)(6) ALLEGEDLY SUFFERED A PERFORATION DURING THE PROCEDURE THAT RESULTED IN SEVERE BLEEDING. THE MANUFACTURED RECEIVED INFORMED ON MAY 22ND THAT THE PATIENT HAD PASSED AWAY.

  Patient problems: Perforation of Vessels

  MAUDE report 19534300 ↗

Other Canon Inc. products

• TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan2 models · 1 reports · 2 recalls
• DIAGNOSTIC ULTRASOUND SYSTEM5 models · 1 reports · 1 recall