Device recall

Z-0928-2014: XiO RTP System. Used to create treatment plans for any cancer patient for whom…

FDA device recall · Class II · Elekta, Inc.

Key facts

Recall number (Z-number) Z-0928-2014
Recall event 67224
Product XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Product code MUJ
Recalling firm Elekta, Inc.
Recall class Class II
Status Terminated
Termination date Dec 2, 2015
510(k) numbers K102216
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

Browse all FDA device recalls (products)