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