Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM
Medical device recall Z-1269-2021. 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-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.
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-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…
Every code shown here, 1,998 characters
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…
FDA’s list runs to 3,142 characters. The first part is shown; the rest is on FDA’s record.
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.”
- FDA’s list of codes runs to 3,142 characters; the first part is shown here, and the rest is on FDA’s record.
- 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
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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.