INTERVENTIONAL ANGIOGRAPHY SYSTEM INFX-8000FRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

11 other recalls cover devices cleared under the same FDA submission (K081624, K182415); 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.

Recalls naming this device

1. 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081624, K182415. 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-1177-2026 · Dec 19, 2025 · Open, Classified
  Alphenix INFX-8000F, interventional fluoroscopic x-ray system
• 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-1176-2021 · Feb 5, 2021 · Open, Classified
  System INFX-8000F
• Z-1271-2021 · Dec 8, 2020 · Open, Classified
  Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for us
• Z-2327-2020 · Mar 3, 2020 · Open, Classified
  Infinix-8000F 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-0360-2020 · Feb 8, 2019 · Terminated
  Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography Syste
• Z-0842-2018 · Dec 29, 2017 · Terminated
  INFX-8000F 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.
• 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
• Z-0005-2009 · Sep 29, 2008 · Terminated
  Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.