Device recall

Z-2138-2018: 12C

FDA device recall · Class II · Ion Beam Applications S.A.

Key facts

Recall number (Z-number) Z-2138-2018
Recall event 80221
Product 12C
Product code LHN
Recalling firm Ion Beam Applications S.A.
Recall class Class II
Status Terminated
Termination date Feb 8, 2019
510(k) numbers K132847
FEI number 3000256071

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)