Canon Medical Recalls Infinix DP-i Catheterization Tables Due to Unintended Tilting
Canon Medical System, USA, INC. is recalling nine Infinix DP-i catheterization tables because liquid spills can trigger a short circuit, causing the table to tilt without operator control.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural/mechanical defect in a medical device that can cause unintended movement of a patient, posing a significant risk of injury, which aligns with the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
Canon Medical System, USA, INC. is recalling nine units of the Infinix DP-i (Infinix-8000F) CAT-870B Catheterization Table (Titling). These tables are used with the Infinix-8000F System to position patients during diagnostic and interventional x-ray angiography.
The recall is being conducted because liquid spilling into the tilt console can trigger a short circuit. This malfunction causes the table to tilt without operator involvement. The affected units were distributed worldwide, including in the United States (AL, CT, FL, IL, OR, PA, and TX) and the Netherlands.
Hospitals and healthcare facilities should stop using the affected catheterization tables and contact Canon Medical System, USA, INC. for further instructions on the recall.
The recalled product
- Product
- Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.
- Manufacturer
- Canon Medical System, USA, INC.
- Affected units
- 9
Distribution
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- Severe
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