Accuray Incorporated

Entity profile compiled from public source records

Public Record Profile Registrations: 1 510(k) filings: 0 Recalls: 2

Known Identifiers & Locations

FEI Numbers 1000123585, 3003873069
Owner Operator Numbers 9005157
Locations Covered MADISON, WI, US

Registered Establishments (1)

Registration # Establishment Name Location Establishment Type(s) Action
3003873069 Accuray Incorporated MADISON, WI, US Manufacture Medical Device View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (2)

Recall # Product Description Initiation Date Status Action
Z-0035-2012 CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA Reason: A report and investigation determined that the set screws, which were part of the retrofit of a previous recall were incorrectly engaged which allowed rotation and subsequent descent of the assembly. 2011-09-12 Terminated View Details
Z-0036-2012 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 Reason: A report and investigation determined that the set screws, which were part of the retrofit of a previous recall were incorrectly engaged at one facility which allowed rotation and subsequent descent of the assembly. 2011-09-12 Terminated View Details

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