The Recall Desk

FDA (Devices) recall action 87322

Canon Medical System, USA, INC. recalled 3 products on 2021-03-24

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
2021-03-24
Critical
0
Units
435

Why these products were recalled

System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.

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)··2021-03-24

    Canon Catheterization Table Recall Due to Potential Tilt Hazard

    Canon is recalling 145 INTERVENTIONAL ANGIOGRAPHY SYSTEMS because table fastening bolts may loosen, causing the table to tilt.

    Product
    Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and…
    Category
    Distribution
    35 states
  • HighFDA (Devices)··2021-03-24

    Canon Medical Recalls Catheterization Tables Due to Potential Tilt Hazard

    Canon Medical System is recalling 145 INTERVENTIONAL ANGIOGRAPHY SYSTEMS because loose bolts may cause the table to tilt.

    Product
    Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and…
    Category
    Distribution
    35 states
  • HighFDA (Devices)··2021-03-24

    Canon Catheterization Table Recall Due to Potential Tilt Hazard

    Canon Medical System is recalling 145 interventional angiography systems because the table may tilt if fastening bolts become loose.

    Product
    Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and…
    Category
    Distribution
    35 states