Device recall

Z-0890-2011: CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic…

FDA device recall · Class II · Accuray Inc

Key facts

Recall number (Z-number) Z-0890-2011
Recall event 56326
Product CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System radiation therapy device, manufactured by Accuray Inc., Sunnyvale, CA. Medical device indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions…
Product code MUJ
Recalling firm Accuray Inc
Recall class Class II
Status Terminated
Termination date Oct 4, 2011
510(k) numbers K091146
FEI number 1000123585

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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