Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C 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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Canon Medical System, USA, INC.
Reason for Recall:
System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C 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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1270-2021

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