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.

Recall Insight

This FDA Devices action (record #Z-2327-2020) was formally reported on June 17, 2020, with the manufacturer initiating the action on March 3, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Canon Medical System, USA, INC. is listed as the recalling firm, operating out of Tustin, CA. Federal records indicate 15 units are affected.

The documented reason for this recall is: Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.