Device recall

Z-2034-2008: BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D…

FDA device recall · Class II · Medtronic Navigation, Inc.

Key facts

Recall number (Z-number) Z-2034-2008
Recall event 49501
Product BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images of human anatomy for surgical applications.
Product code JAA
Recalling firm Medtronic Navigation, Inc.
Recall class Class II
Status Terminated
Termination date Dec 4, 2008
510(k) numbers K050996
FEI number 3004785967

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)