FDA Device recall Z-1269-2021
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 2…
- FDA Device
- Class II
- ongoing
- Published 2021-03-24
On 2021-03-24 the FDA classified a Class II recall of Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 2… by Canon Medical System Usa, citing system table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1269-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-12-08 |
| Published | 2021-03-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Canon Medical System Usa |
| Distribution | US |
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.
Reason
System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
Identifiers
| code_info | Table CAT-880B Models: INFX-8000V/A6 INFX-8000V/AA INFX-8000V/AC INFX-8000V/A8 INFX-8000V/U7 INFX-8000V/AA INFX…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-10-14 · Canon Medical System Usa - Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and intervent…
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FDA Device · Class II · 2026-02-04 · Canon Medical System Usa - Alphenix INFX-8000H, interventional fluoroscopic x-ray system
FDA Device · Class II · 2026-02-04 · Canon Medical System Usa - Alphenix INFX-8000F, interventional fluoroscopic x-ray system
FDA Device · Class II · 2026-02-04 · Canon Medical System Usa
All Canon Medical System Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1269-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.