FDA recall Z-2325-2020

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

Product

Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

Reason for recall

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

Distribution

US Nationwide distribution including in the states of PA, AR, OH, NC, CA, IA, GA, IL, AL, WV, LA, MO, FL, MS, TX, AZ, MA, NJ, MD, NY, NV, OK, WI, PR.

Key facts

Status
Ongoing
Initiation date
2020-03-03
Report date
2020-06-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tustin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2325-2020