The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2326-2020·Announced 2020-06-17

Canon Medical System Recalls 24 Infinix-8000C Digital Radiography Systems

Canon Medical System is recalling 24 Infinix-8000C digital radiography 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect in a medical device (loose bolts causing table tilting) which poses a significant risk of injury to patients or staff, meeting the criteria for a Severe (Score 4) classification.

Plain-English summary

Canon Medical System, USA, INC. is recalling 24 units of the Infinix-8000C digital radiography/fluoroscopy system. These devices are used in diagnostic and interventional angiography configurations for procedures on blood vessels in the heart, brain, abdomen, and lower extremities. The recall involves systems equipped with either the CAT-850B or CAT-860B catheterization tables.

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 stop using the affected devices and contact Canon Medical System for further instructions. The specific serial numbers for the 24 affected units are listed in the official recall documentation.

The recalled product

Product
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 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
24

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: B8B1972001
  • A9A1592001
  • A3A14Z2001
  • AEB1812002
  • A1B1552001
  • A9C18Y2007
  • A3E1922002
  • B5B1952001
  • A9C1822006
  • A9B1622002
  • A9B1722003
  • A5C1622001
  • B3B19Y2001
  • A1D1772003
  • B1B19X2001
  • A5C16Y2002
  • A9C1822005
  • A1E1862008
  • A1D1752002
  • A1E1832004

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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