Canon Catheterization Table Recall Due to Potential Tilt Hazard
Canon is recalling 145 INTERVENTIONAL ANGIOGRAPHY SYSTEMS because table fastening bolts may loosen, causing 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 medical device with a mechanical defect that poses a risk of harm (table tilting) during procedures, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Canon Medical System, USA, INC. is recalling 145 units of the Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V, 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 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 products were distributed nationwide in the United States and in Canada, China, Japan, Korea, and Singapore. The source text does not specify the number of reported injuries or illnesses associated with this defect.
The recalled product
- 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…
- 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.
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