Device recall

Z-0828-2014: Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale…

FDA device recall · Class II · Accuray Incorporated

Key facts

Recall number (Z-number) Z-0828-2014
Recall event 67278
Product Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
Product code IYE
Recalling firm Accuray Incorporated
Recall class Class II
Status Terminated
Termination date Nov 25, 2014
510(k) numbers K122137
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

Browse all FDA device recalls (products)