TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.

Recall Insight

This FDA Devices action (record #Z-0864-2019) was formally reported on February 27, 2019, with the manufacturer initiating the action on January 14, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Shimadzu Medical Systems Usa Com is listed as the recalling firm, operating out of Torrance, CA. Federal records indicate 13 units units are affected.

The documented reason for this recall is: Two issues: Event 1: Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and … Distribution data in the federal record shows the product reached: FL, MT, CT, OH, IL, TX, MS, LA, SC. 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 7 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.