INTERVENTIONAL ANGIOGRAPHY SYSTEM INFX-8000CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987670100192), received between Feb 12, 2025 and Mar 13, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Unexpected Mode Switch” (1 report).

4 FDA recall records name this device's identifier, 4 still open.

7 other recalls cover devices cleared under the same FDA submission (K113052, K152697, K181804); 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.

Recalls naming this device

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

3. 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 · FDA record ↗

4. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113052, K152697, K181804. One submission often covers many models, so check the product and lot details in each record.

• Z-0492-2022 · Dec 20, 2021 · Open, Classified
  Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
• Z-1175-2021 · Feb 5, 2021 · Open, Classified
  System INFX-8000C
• Z-1270-2021 · Dec 8, 2020 · Open, Classified
  Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for us
• Z-0532-2021 · Oct 8, 2020 · Terminated
  CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000H - Product Usage: This device
• Z-2326-2020 · Mar 3, 2020 · Open, Classified
  Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angio
• Z-0843-2018 · Dec 29, 2017 · Terminated
  INFX-8000C Fluoroscopic X-Ray Systems
• Z-0994-2013 · Nov 8, 2012 · Terminated
  Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.