Device recall

Z-3030-2026: FUJIFILM Synapse PACS software v7.4.310; radiological image processing system

FDA device recall · Class II · FUJIFILM Healthcare Americas Corporation

Key facts

Recall number (Z-number) Z-3030-2026
Recall event 99529
Product FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Product code LLZ
Recalling firm FUJIFILM Healthcare Americas Corporation
Recall class Class II
Status Open, Classified
510(k) numbers K190232
FEI number 1000513161

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)