Device recall

Z-0704-2007: InstaTrak 3500 Plus system with cranial application (aid to the surgeon for…

FDA device recall · Class II · GE OEC Medical Systems,Inc

Key facts

Recall number (Z-number) Z-0704-2007
Recall event 31058
Product InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body)
Product code LLZ
Recalling firm GE OEC Medical Systems,Inc
Recall class Class II
Status Terminated
Termination date Jul 8, 2011
510(k) numbers K983529
FEI number 1720753

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)