Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported March 24, 2021
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.
System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
Canon Medical System, USA, INC. recalled Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-88… - a moderate-severity action.
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-88… was recalled by Canon Medical System, USA, INC. in March 24, 2021. Reason: System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit …. Check the official notice for the remedy. Verify recall #Z-1269-2021 with the FDA Devices before acting.
The recall
Canon Medical System, USA, INC. issued this moderate-severity FDA Devices recall-System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit ….
- Moderate
- severity level
- Class II
- classification
- March 24, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1269-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1269-2021) was formally reported on March 24, 2021, with the manufacturer initiating the action on December 8, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Canon Medical System, USA, INC. is listed as the recalling firm, operating out of Tustin, CA. Federal records list the affected scope as Total of all Systems = 145 systems (U.S.).
The documented reason for this recall is: System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose. Distribution data in the federal record shows the product reached: 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…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Total of all Systems = 145 systems (U.S.)
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1269-2021 |
| Date reported | March 24, 2021 |
| Date initiated | December 8, 2020 |
| Recalling firm | Canon Medical System, USA, INC. |
| Firm location | Tustin, CA |
| Affected scope | Total of all Systems = 145 systems (U.S.) |
| Distribution | 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 o… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1269-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was 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.. Recalled by Canon Medical System, USA, INC.. Units affected: Total of all Systems = 145 systems (U.S.).
Why was this product recalled? ▼
System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 24, 2021. Severity: Moderate. Recall number: Z-1269-2021.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1269-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 24, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.