medical Class II Updated 2020-06-17

Canon Medical System, USA, INC. recalls Infinix-8000C with Catheterization Table CAT-850B or CAT-860

Recalled Product

Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This 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.

Hazard / Issue

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: B8B1972001, A9A1592001, A3A14Z2001, AEB1812002, A1B1552001, A9C18Y2007, A3E1922002, B5B1952001, A9C1822006, A9B1622002, A9B1722003, A5C1622001, B3B19Y2001, A1D1772003, B1B19X2001, A5C16Y2002, A9C1822005, A1E1862008, A1D1752002, A1E1832004, A1E1852005, A1E1852006, A5E1862003, AEA17X2001
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