The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2325-2020·Announced 2020-06-17

Canon Medical System Recalls Infinix-8000V Catheterization Tables Due to Loose Bolts

Canon Medical System is recalling 46 Infinix-8000V systems because loose bolts may cause the catheterization table to tilt.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 poses a risk of harm (table tilting) but the source text does not report any 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 46 units of the Infinix-8000V digital radiography/fluoroscopy system equipped with a CAT-850B or CAT-860B catheterization table. The recall is due to a defect where bolts holding the longitudinal movement of the table may be loose. This condition may lead to the table surface or top tilting.

The affected devices are 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. The source text does not report any injuries or illnesses associated with this defect.

Healthcare facilities should contact Canon Medical System to arrange for the inspection and repair of the affected units. The recall number for this action is Z-2325-2020.

The recalled product

Product
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 angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for…
Manufacturer
Canon Medical System, USA, INC.
Category
Medical Device — Radiography/Fluoroscopy
Hazard
Affected units
46

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 (20)

  • Serial Numbers: A5B1642006
  • A1B17X2004
  • A5A1612005
  • A5B1772009
  • B5B1962002
  • A3A1522004
  • A7B16Y2001
  • A3A1712011
  • A5B1792010
  • A5A1532002
  • A1A1612003
  • A3A15Z2007
  • A5A1552003
  • A5B16Y2007
  • A3B1862016
  • A3B1812013
  • A3A1662009
  • A9A16X2004
  • BTA1922001
  • A3B1842015

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 →

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