The Recall Desk

FDA (Devices) recall action 85309

Canon Medical System, USA, INC. recalled 3 products on 2020-06-17

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2020-06-17
Critical
0
Units
85

Why these products were recalled

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    25 states
  • SevereFDA (Devices)··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.

    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
    Category
    Distribution
    25 states
  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    25 states