Reported Jun 17, 2020 · Ongoing
Infinix-8000V 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-8000V 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
A5B1642006A1B17X2004A5A1612005A5B1772009B5B1962002A3A1522004A7B16Y2001A3A1712011A5B1792010A5A1532002A1A1612003A3A15Z2007A5A1552003A5B16Y2007A3B1862016A3B1812013A3A1662009A9A16X2004BTA1922001A3B1842015AOB1882001BMB1942001AOB1892002A5B1472001A5B17Z2011A3A14X2002A5A1592004A3A17Z2012A5C1832012A5B16Z2008A1A1582002A9A1582002A1A14X2001A3A1512003A7C1812002ABC18X2002A3A1592005UTC14Y2008A3A15X2006B5B1942001A3A1682010A1C18Z2005A9A1662003A3A1492001A3B1822014A3A1622008
- Serial Numbers
- Amount recalled
- 46
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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