FDA recall Z-0360-2020

Canon Medical System, USA, INC. · Class II · device

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.

Reason for recall

Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.

Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, CT, FL, IL, OR, PA, and TX; and country of Netherlands.

Key facts

Status: Terminated
Initiation date: 2019-02-08
Report date: 2019-11-20
Termination date: 2022-06-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tustin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0360-2020