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.
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 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…
- 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
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