Reported Mar 24, 2021 · Ongoing

Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization Table CAT-880B Canon CATHETERIZATION TABLE,…

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?

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

Lot codes and dates: Table CAT-880B Models
INFX-8000C/B6
INFX-8000C/B6
INFX-8000C/B4UP
INFX-8000C/B4
INFX-8000C/UP
INFX-8000C/UE
INFX-8000C/U5
INFX-8000C/B4
INFX-8000C/A6
INFX-8000C/B6
INFX-8000C/A6
INFX-8000C/A6
INFX-8000C/A6
INFX-8000C/UP
INFX-8000C/A6
INFX-8000C/UP
INFX-8000C/AF
INFX-8000C/A6
INFX-8000C/BF
INFX-8000C/A4
INFX-8000C/UE
INFX-8000C/A2
INFX-8000C/A6
INFX-8000C/UP
INFX-8000C/A6
INFX-8000C/UE
INFX-8000C/UE
INFX-8000C/UC
INFX-8000C/AF
INFX-8000C/AF
INFX-8000C/A6
INFX-8000C/A6
INFX-8000C/AF/VL72-2015B
INFX-8000C/AF
INFX-8000C/BF
INFX-8000C/B2
INFX-8000C/BF
INFX-8000C/B4
INFX-8000C/BF
INFX-8000C/BF
INFX-8000C/BF
INFX-8000C/BF
INFX-8000C/A6
INFX-8000C/A4
INFX-8000C/BF Table Serial Number
B1C2072072
B1C2072070
B1C2032061
B1B19Z2048
99A1332131
99B1352138
99A1292103
B1B19X2040
99F1872415
B1A1942012
99E16X2327
99F1872409
99E1542247
99B1372146
99C1472196
99B1352139
99F1832396
99E1582259
B1A1932005
99C1472199
99A1312122
99F1812388
99F1872414
99B1342135
99E1682315
99B1342133
99B1342134
99A1332130
99F1872413
99f1872411
99F1852400
99E1742355
99E1662307
99F1892424
CTC18Y2004
B1B1972026
B1B1972029
B1B19Z2046
B1C2062066
B1A1952017
B1B1972025
B1A1942009
99C1492202
99C13Z2171
B1C2012051 System Serial Numbers
B6C2072003
B6C2072002
B4C2032004
B4B19Z2003
UPA1332003
UEB1352004
U5C1292001
B4B19X2001
A6C1872011
B6B1942001
A6B16X2006
A6C1872009
A6B1532003
UPB1372006
U6A1472001
UPB1352005
AFB1832003
A6B1582004
BFA1932001
A4B1472002
UEA1312001
A2C1812002
A6C1872010
UPB1342004
A6B1682005
UEB1347001
UEB1347002
UCA1022004
AFB1872005
AFB1872004
A6C1852008
A6B1742007
AFA1662001
AFB1892006
BFA18Y7001
B2B1972001
BFB1972005
B4B19Z2002
BFC2062007
BFB1952003
BFB1972004
BFB1942002
A6A1492002
A4A13Z2001
TEMPPM007995
Amount recalled: Total of all Systems = 145 systems (U.S.)

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

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

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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By hazard

Medical device recalls

Other recalls from Canon Medical System, USA, Inc.

Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital… Sep 2, 2026
Alphenix INFX-8000C, interventional fluoroscopic x-ray system Feb 4, 2026
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 Jan 21, 2026
VANTAGE GALAN 3T. CMSC Nov 5, 2025
This device is a digital radiography/fluoroscopy system used in a diagnostic and… Oct 15, 2025
Cartesion Prime, Digital PET-CT Nov 13, 2024

26 in total.

Where it was distributed

All recall categories · Browse the whole archive