Trinias 503-79402-33Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

7 other recalls cover devices cleared under the same FDA submission (K123508); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 15, 2018Class IITerminated

   Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel.

   Z-0197-2019 · Root cause: Software design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123508. One submission often covers many models, so check the product and lot details in each record.

• Z-2294-2026 · Apr 20, 2026 · Open, Classified
  Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST alexa:UD150G-40 / D1
• Z-0139-2025 · Sep 6, 2024 · Open, Classified
  Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image process
• Z-1292-2024 · Jan 29, 2024 · Open, Classified
  Shimadzu, Trinias, Digital Angiography System
• Z-0655-2022 · Dec 16, 2021 · Open, Classified
  Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
• Z-0555-2021 · Nov 18, 2020 · Open, Classified
  Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, ab
• Z-2591-2020 · Nov 4, 2019 · Completed
  Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as
• Z-0864-2019 · Jan 14, 2019 · Terminated
  TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiograph