Device recall

Z-1292-2024: Shimadzu, Trinias, Digital Angiography System

FDA device recall · Class II · SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

Key facts

Recall number (Z-number) Z-1292-2024
Recall event 93933
Product Shimadzu, Trinias, Digital Angiography System
Product code OWB
Recalling firm SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Recall class Class II
Status Open, Classified
510(k) numbers K123508
FEI number 3002808139

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)