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.
Reported: November 20, 2019 Initiated: February 8, 2019 #Z-0360-2020
Product Description
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.
Reason for Recall
Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.
Details
- Recalling Firm
- Canon Medical System, USA, INC.
- Units Affected
- 9 systems
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, CT, FL, IL, OR, PA, and TX; and country of Netherlands.
- Location
- Tustin, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Canon Medical System, USA, INC.. Units affected: 9 systems.
Why was this product recalled? ▼
Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2019. Severity: Moderate. Recall number: Z-0360-2020.
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