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.
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 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 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.
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