Canon Medical System, USA, INC.: Medical Device Recall in 2020 - (Recall #: Z-2327-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Infinix-8000F 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.

Product Classification:

Class II

Date Initiated: March 3, 2020

Date Posted: June 17, 2020

Recall Number: Z-2327-2020

Event ID: 85309

Reason for Recall:

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

Status: Ongoing

Product Quantity: 15

Code Information:

Serial Numbers: AGB1692005, AGB17Z2010, AGA1552003, AGB17Y2009, AGB1682004, AGA1492002, AGC1822012, A5C1922001, AGB1712007, AGC1952014, AGB1482001, AGC1822011, BGB1992001, AGC18X2013, AGB16Z2006

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated