Device recall

Z-2294-2026: Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography…

FDA device recall · Class II · Shimadzu Medical Systems

Key facts

Recall number (Z-number) Z-2294-2026
Recall event 98571
Product Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST alexa:UD150G-40 / D150GC-40; Digital Radiography System RADspeed Pro: UD150B-40 / UD150V-40 / UD150L-40 / UD150L-40E/D150BC-40 / D150VC-40 /…
Product code OWB
Recalling firm Shimadzu Medical Systems
Recall class Class II
Status Open, Classified
510(k) numbers K062360, K123508, K152244, K233722
FEI number 1000125362

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)