The Recall Desk
HighFDA (Devices)·Z-2327-2020·Announced 2020-06-17

Canon Medical System Recalls Infinix-8000F Fluoroscopy Systems Due to Loose Bolts

Canon Medical System is recalling 15 Infinix-8000F digital radiography systems because loose bolts may cause the catheterization table to tilt.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device that could lead to injury, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Canon Medical System, USA, INC. is recalling 15 units of the Infinix-8000F digital radiography/fluoroscopy system. These systems are used in diagnostic and interventional angiography configurations for procedures involving blood vessels in the heart, brain, abdomen, and lower extremities. The recall involves specific models equipped with the Catheterization Table CAT-850B or CAT-860B.

The recall is being issued because bolts holding the longitudinal movement of the catheterization tables may be loose. This defect may lead to the table surface or top tilting. The affected units were distributed nationwide in the United States, including in Pennsylvania, Arkansas, Ohio, North Carolina, California, Iowa, Georgia, Illinois, Alabama, West Virginia, Louisiana, Missouri, Florida, Mississippi, Texas, Arizona, Massachusetts, New Jersey, Maryland, New York, Nevada, Oklahoma, Wisconsin, and Puerto Rico.

Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Users should contact Canon Medical System for instructions on how to resolve the issue.

The recalled product

Product
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 angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for
Manufacturer
Canon Medical System, USA, INC.
Category
Medical Device — Radiology / Fluoroscopy
Hazard
Affected units
15

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • Serial Numbers: AGB1692005
  • AGB17Z2010
  • AGA1552003
  • AGB17Y2009
  • AGB1682004
  • AGA1492002
  • AGC1822012
  • A5C1922001
  • AGB1712007
  • AGC1952014
  • AGB1482001
  • AGC1822011
  • BGB1992001
  • AGC18X2013
  • AGB16Z2006

Distribution

Distributed nationwide across the United States.

The notice also names 25 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Canon Medical System, USA, INC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Canon Medical System, USA, INC.

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Same hazard · structural defect

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