Device recall

Z-0622-06: Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS

FDA device recall · Class II · Fujifilm Medical System USA, Inc.

Key facts

Recall number (Z-number) Z-0622-06
Recall event 34652
Product Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS
Product code LLZ
Recalling firm Fujifilm Medical System USA, Inc.
Recall class Class II
Status Terminated
Termination date Mar 16, 2012
510(k) numbers K051553
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

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