Device recall

Z-0036-2012: CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System…

FDA device recall · Class II · Accuray Incorporated

Key facts

Recall number (Z-number) Z-0036-2012
Recall event 59937
Product CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Product code IYE
Recalling firm Accuray Incorporated
Recall class Class II
Status Terminated
Termination date Feb 27, 2012
510(k) numbers K102650
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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