Device recall

Z-0399-06: ''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication…

FDA device recall · Class II · Stentor Inc

Key facts

Recall number (Z-number) Z-0399-06
Recall event 34270
Product ''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3
Product code LLZ
Recalling firm Stentor Inc
Recall class Class II
Status Terminated
Termination date Apr 14, 2006
510(k) numbers K042292
FEI number 3002971142

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)