Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM
Medical device recall Z-1270-2021. Published in FDA’s Enforcement Report on Mar 24, 2021.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 24, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 35 states named
- Total of all Systems = 145 systems (U.S.) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
Total of all Systems = 145 systems (U.S.), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,701 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, WA, WI and WV. The countries of Canada, China, Japan, Korea, and Singapore.
The states and territories these words name
35 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Montana
- North Carolina
- New Jersey
- New York
- Ohio
- Oklahoma
- Pennsylvania
- South Dakota
- Tennessee
- Texas
- Washington
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 8, 2020.
- FDA classified it on Mar 17, 2021.
- FDA’s Enforcement Report published it on Mar 24, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Canon Medical System, USA, INC., of Tustin, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.