INTERVENTIONAL ANGIOGRAPHY SYSTEM INFX-8000VRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987670100222), received between Jun 13, 2024 and May 14, 2026 — classified as 1 death, 2 malfunctions.

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

12 other recalls cover devices cleared under the same FDA submission (K081582, K112054, K120073, K133535, K143225, K152696, K162614, K170909, K172863, K181670, K203551, K251602, K253584); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

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.

• 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 ↗
• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081582, K112054, K120073, K133535, K143225, K152696, K162614, K170909, K172863, K181670, K203551, K251602, K253584. One submission often covers many models, so check the product and lot details in each record.

• Z-3014-2026 · Aug 4, 2026 · Open, Classified
  Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The sys
• Z-1666-2022 · Jan 31, 2022 · Open, Classified
  INFX-8000V. For radiographic and fluoroscopic studies and intervention.
• 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-1174-2021 · Feb 5, 2021 · Open, Classified
  System INFX-8000V
• Z-1269-2021 · Dec 8, 2020 · Open, Classified
  Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for u
• Z-2325-2020 · Mar 3, 2020 · Open, Classified
  Infinix-8000V 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-0844-2018 · Dec 29, 2017 · Terminated
  INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
• Z-0752-2016 · Aug 14, 2015 · Terminated
  INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
• Z-1394-2015 · Mar 11, 2015 · Terminated
  INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canad
• Z-1714-2014 · May 12, 2014 · Terminated
  Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
• 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.
• Z-0331-2012 · Oct 3, 2011 · Terminated
  Model CAT-850B Catheterization Table, a component of the Toshiba INFX-8000 series X-Ray Interventional System. These systems are single or dual plane systems that employ x-rays to