Device recall

Z-2002-2012: Focal SIM Planning of radiation therapy

FDA device recall · Class II · Elekta, Inc.

Key facts

Recall number (Z-number) Z-2002-2012
Recall event 62433
Product Focal SIM Planning of radiation therapy
Product code MUJ
Recalling firm Elekta, Inc.
Recall class Class II
Status Terminated
Termination date Apr 1, 2014
510(k) numbers K013112
FEI number 1037831

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

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