The Recall Desk
SevereFDA (Devices)·Z-0360-2020·Announced 2019-11-20

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
Category
Medical Device — Imaging Equipment
Hazard
Affected units
9

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

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