Canon Medical System, USA, INC.: System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.

Agency Publication Date: March 17, 2021

Affected Products

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.

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

Product: Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V 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.

Table CAT-880B Models: INFX-8000V/A6 INFX-8000V/AA INFX-8000V/AC INFX-8000V/A8 INFX-8000V/U7 INFX-8000V/AA INFX-8000V/U7 INFX-8000V/UF INFX-8000V/BN INFX-8000V/BU INFX-8000V/UD INFX-8000V/UL INFX-8000V/A6 INFX-8000V/AC INFX-8000V/AA INFX-8000V/UU INFX-8000V/A6 INFX-8000V/U5 INFX-8000V/BAUP INFX-8000V/A2 INFX-8000V/A2 INFX-8000V/A4 INFX-8000V/UL INFX-8000V/UL INFX-8000V/UL INFX-8000V/A4 INFX-8000V/BG INFX-8000V/BG INFX-8000V/A6 INFX-8000V/AA INFX-8000V/AA INFX-8000V/AA INFX-8000V/AA INFX-8000V/BQ INFX-8000V/UU INFX-8000V/BL INFX-8000V/BL INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/AC INFX-8000V/BL INFX-8000V/UF INFX-8000V/UF INFX-8000V/BY INFX-8000V/BS INFX-8000V/A6 INFX-8000V/AA INFX-8000V/AC INFX-8000V/UF INFX-8000V/UF INFX-8000V/B6 INFX-8000V/UF INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/U7 INFX-8000V/UU INFX-8000V/UD INFX-8000V/BC INFX-8000V/UU INFX-8000V/BG INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/A4 INFX-8000V/UL INFX-8000V/A8/VL63-2015B/A INFX-8000V/AA INFX-8000V/A8 INFX-8000V/A4 INFX-8000V/BY INFX-8000V/BY INFX-8000V/UF INFX-8000V/AA INFX-8000V/A8 INFX-8000V/A4 INFX-8000V/AA INFX-8000V/A6 INFX-8000V/B2 INFX-8000V/BU INFX-8000V/UU INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/UU INFX-8000V/BQ Table Serial Numbers: 99E15X2267 99E1692317 99C1472192 99E16Y2329 99A12X2107 99E1542248 99C1462190 99C1442183 B1B19Y2043 B1A1942008 99A1292104 99A1322127 99E15Y2275 99C1492204 99C1492205 99A12Z2117 99E1742358 99A1272094 B1C2012053 99F18X2427 99F1952435 99D1522239 99A12Z2118 99C1392151 99C1452189 99F1862408 B1B1962022 B1B1962021 99E1652304 99F1862407 99E17X2373 99E17X2374 99E17X2375 B1B1962023 99A12X2108 B1C2022054 B1B1992039 99E16X2328 99E1622292 99E16Y2338 B1A1952015 99A12X2109 99C1452184 B1B1992038 B1C2052064 99C14Z2230 99F1882417 99E1622293 99C13X2156 99C13X2155 B1C2072071 99B1362141 99F1862403 99H2032441 99E17Z2380 99A1322125 99C13Z2167 99A1322123 B1B19X2041 99A12X2106 B1C2072073 99E16Y2336 99E1612287 99C14X2207 99C1452185 99E17Z2382 99F1842398 99E1532243 99C14Z2232 B1A1932006 B1A1932004 99A12Z2116 99E1712346 99E17X2372 99C1512236 99C14X2206 99E1582261 B1B1962020 B1B1982033 99C1452186 99F1862402 99F1862405 99E16Z2340 99A1312120 B1C2082075 System Serial Numbers: A6A15X2003 AAA1692006 ACA1472001 A8B16Y2002 U7D12X2007 A9A1542001 U7E1462009 UFD1442017 BNB19Y2001 BUB1942001 UDA0952001 ULC1322012 A6A15Y2004 ACA1492002 AAA1492001 UUB12Z2009 A6B1742011 U5E1272003 BAD2012001 A2C18X2001 A2C1952002 A4A1522004 ULC1282010 ULD1392013 ULD1452016 A4B1862007 BGB1962002 BGB1962001 A6B1652007 AAB1862012 AAA17X2008 AAA17X2009 AAA17X2010 BQB1962001 UUB12X2008 BLD2022003 BLB1992002 A6B16X2008 A6B1622006 ACB16Y2004 BLB1952001 UFC12X2011 UFD1452018 BYB1992003 BSD2052001 A6A14Z2001 AAB1882013 ACB1622003 UFD13X2016 UFD13X2015 B6D2072001 UFD1362014 A6C1862014 A6C2032016 A6B17Z2012 U7D1322008 UUC13Z2011 UDD1322016 BCB19X2001 UUB12X2007 BGD2072003 A6B16Y2009 A6A1612005 A4A14X2001 ULD1452015 A8B17Z2004 AAB1842011 A8A1532001 A4A14Z2002 BYA1932002 BYA1932001 UFC12Z2013 AAA1712007 A8B17X2003 A4A1512003 AAA14X2002 A6A1582002 B2B1962001 BUB1982002 UUC1452012 A6C1862013 A6C1862015 A6B16Z2010 UUB1312010 BQD2082002

Product: 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.

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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87322

Status: Active

Manufacturer: Canon Medical System, USA, INC.

Manufactured In: United States

Units Affected: 3 products (Total of all Systems = 145 systems (U.S.))

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products