Reported Mar 24, 2021 · Ongoing

Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE,…

Canon Medical System, USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Canon Medical System, USA, INC. · 2441 Michelle Dr · Tustin, CA · 92780-7047

Is this the product you have?

  • Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL
  • CAT-880B INPUT 220V - Product Usageindicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities
Lot codes and dates
  • Table CAT-880B Models
    • INFX-8000F/AH
    • INFX-8000F/AH
    • INFX-8000F/AH
    • INFX-8000F/AH
    • INFX-8000F/AH
    • INFX-8000F/BHUP
    • INFX-8000F/AH
    • INFX-8000F/AH
    • INFX-8000F/UU
    • INFX-8000F/AH
    • INFX-8000F/AH
    • INFX-8000F/AH
    • INFX-8000F/AH
    • INFX-8000F/AH
    • INFX-8000F/AH
  • INFX-8000F/BH Table Serial Numbers
    • 99E1582258
    • 99F18Y2428
    • 99C1482200
    • 99E15Y2271
    • 99F1862406
    • 99G19Z2438
    • 99E1662308
    • 99E1762365
    • 99A1337005
    • 99F1852401
    • 99E1612286
    • 99E1712347
    • 99E1712345
    • 99C14Z2224
    • 99E1592262
    • 99G1972436
  • System Serial Numbers
    • AHA1582003
    • AHC18Y2013
    • AHA1482001
    • AHA15Y2005
    • AHC1862012
    • BHB19Z2002
    • AHB1662007
    • AHB1762010
    • UUB12X2034
    • AHC1852011
    • AHA1612006
    • AHB1712009
    • AHB1712008
    • AHA14Z2002
    • AHA1592004
    • BHB1972001
Amount recalled
Total of all Systems = 145 systems (U.S.)

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.