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/AHINFX-8000F/AHINFX-8000F/AHINFX-8000F/AHINFX-8000F/AHINFX-8000F/BHUPINFX-8000F/AHINFX-8000F/AHINFX-8000F/UUINFX-8000F/AHINFX-8000F/AHINFX-8000F/AHINFX-8000F/AHINFX-8000F/AHINFX-8000F/AH
- INFX-8000F/BH Table Serial Numbers
99E158225899F18Y242899C148220099E15Y227199F186240699G19Z243899E166230899E176236599A133700599F185240199E161228699E171234799E171234599C14Z222499E159226299G1972436
- System Serial Numbers
AHA1582003AHC18Y2013AHA1482001AHA15Y2005AHC1862012BHB19Z2002AHB1662007AHB1762010UUB12X2034AHC1852011AHA1612006AHB1712009AHB1712008AHA14Z2002AHA1592004BHB1972001
- Table CAT-880B Models
- 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.
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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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