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.

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

On 02/08/2019, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification to customers via USPS return receipt mail informing them of the potential problem with the Catheterization Table (CAT-870B) may tilt without operator involvement due to accidental liquid spillage. Customers are instructed to: a. Please keep the tableside console and the x-ray detector of the support units covered with sterile caps as stated in the Caution section of the operation manual. The caps are there to prevent liquids from coming into contact with the tableside console and the x-ray detector. b. If an actual event occurs, please push the emergency switch and call your service representative. c. Please share this information with all users and reviewing radiologist as well as clinical engineering and the biomedical group at your facility. d. Please complete and return the attached form and fax it to the toll free number 877-349-3054. This form may also be sent via email to [email protected]. If customers have any questions regarding this letter, they are free to contact Regulatory Affairs Manager at (800) 421-1968 or their local Representative at (800) 521-1968.