medical Class II Updated 2021-03-24

Canon Medical System, USA, INC. recalls Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F

Recalled Product

Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.

Hazard / Issue

System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Table CAT-880B Models: INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/BHUP INFX-8000F/AH INFX-8000F/AH INFX-8000F/UU INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/BH Table Serial Numbers: 99E1582258 99F18Y2428 99C1482200 99E15Y2271 99F1862406 99G19Z2438 99E1662308 99E1762365 99A1337005 99F1852401 99E1612286 99E1712347 99E1712345 99C14Z2224 99E1592262 99G1972436 System Serial Numbers: AHA1582003 AHC18Y2013 AHA1482001 AHA15Y2005 AHC1862012 BHB19Z2002 AHB1662007 AHB1762010 UUB12X2034 AHC1852011 AHA1612006 AHB1712009 AHB1712008 AHA14Z2002 AHA1592004 BHB1972001
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