Device recall

Z-2919-2011: XiO Radiation Treatment Planning System, XiO versions equal to or greater than…

FDA device recall · Class II · Computerized Medical Systems Inc

Key facts

Recall number (Z-number) Z-2919-2011
Recall event 59102
Product XiO Radiation Treatment Planning System, XiO versions equal to or greater than 2.4.0 and less than 4.63.0 The XiO RTP System is 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 Computerized Medical Systems Inc
Recall class Class II
Status Terminated
Termination date Apr 4, 2013
510(k) numbers K102216
FEI number 1937649

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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