Device recall

Z-2451-2026: Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

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

Key facts

Recall number (Z-number) Z-2451-2026
Recall event 99041
Product Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Product code OWB
Recalling firm Medtronic Navigation, Inc.-Boxborough
Recall class Class II
Status Open, Classified
510(k) numbers K240465
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)