Canon Catheterization Table Recall Due to Potential Tilt Hazard
Canon Medical System is recalling 145 interventional angiography systems because the table may tilt if fastening bolts become loose.
What this means for you
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 the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria.
Plain-English summary
Canon Medical System, USA, INC. is recalling 145 units of the Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F, specifically the Catheterization Table CAT-880B. These systems are indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.
The recall is being issued because the system table may tilt. This hazard occurs because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
The affected units were distributed nationwide in the United States and in Canada, China, Japan, Korea, and Singapore. The source text does not specify the exact actions consumers or healthcare facilities should take, nor does it report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F 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 lowe
- 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 →- 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-8000C 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 →- 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
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereMagic Tilt Watercraft Trailers Recalled Due to Winch Weld Failure
NHTSA · 2026-08-28