Canon Medical Recalls Catheterization Tables Due to Potential Tilt Hazard
Canon Medical System is recalling 145 INTERVENTIONAL ANGIOGRAPHY SYSTEMS because loose bolts may cause the table to tilt.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where a mechanical failure could cause injury, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Canon Medical System, USA, INC. is recalling 145 units of the Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C, specifically the Catheterization Table CAT-880B. The recall covers systems distributed nationwide in the United States and in Canada, China, Japan, Korea, and Singapore.
The recall was initiated because the bolts that fasten the vertical column and the table top tilting drive unit may become loose. This defect may cause the system table to tilt. The affected systems are indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.
Healthcare facilities and users should identify affected units by checking the specific model and serial numbers listed in the official recall documentation. Users should contact Canon Medical System for instructions on how to address the issue.
The recalled product
- 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…
- Manufacturer
- Canon Medical System, USA, INC.
- Affected units
- 145
Distribution
Part of a larger recall action
This product is one of 3 recalled by Canon Medical System, USA, INC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Canon Medical System, USA, INC.
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- HighCanon Medical Alphenix X-ray Systems Recalled for Loose Ceiling Screws
FDA (Devices) · 2026-09-02
- ModerateAlphenix INFX-8000F systems recalled over ceiling suspension screws that loosen
FDA (Devices) · 2026-02-04
- ModerateAlphenix INFX-8000H systems recalled over ceiling suspension screws that loosen
FDA (Devices) · 2026-02-04
- HighQ.namix R fluoroscopy systems recalled over unflipped and mismatched images
FDA (Devices) · 2026-02-04
Same hazard · mechanical failure
See all →- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
Similar recalls
- SevereCanon Medical System Recalls 24 Infinix-8000C Digital Radiography Systems
FDA (Devices) · 2020-06-17
- HighCanon Medical System Recalls Infinix-8000F Fluoroscopy Systems Due to Loose Bolts
FDA (Devices) · 2020-06-17
- HighCanon Medical System Recalls Infinix-8000V Catheterization Tables Due to Loose Bolts
FDA (Devices) · 2020-06-17
- SevereCanon Medical Recalls Infinix DP-i Catheterization Tables Due to Unintended Tilting
FDA (Devices) · 2019-11-20
- HighToshiba INFX-8000V Interventional Angiography System Recall for Brake Defect
FDA (Devices) · 2015-04-15
- HighCanon Medical Alphenix X-ray Systems Recalled for Loose Ceiling Screws
FDA (Devices) · 2026-09-02