Reported Jun 17, 2020 · Ongoing
Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital…
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?
- Infinix-8000F with Catheterization Table
- CAT-850B or CAT-860B - Product UsageThis 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 blood vessels in the heart, brain, abdomen and lower extremities
- Lot codes and dates
- Serial Numbers
AGB1692005AGB17Z2010AGA1552003AGB17Y2009AGB1682004AGA1492002AGC1822012A5C1922001AGB1712007AGC1952014AGB1482001AGC1822011BGB1992001AGC18X2013AGB16Z2006
- Serial Numbers
- Amount recalled
- 15
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
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
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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