FDA Device

RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery System, manufactured by Accuray Incorporated, Sunnyvale, CA. Intended for use in the support and positioning of a patient during Radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.

Hazard

Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches.

What You Should Do

Remedy

Consignees were notified verbally about the issue when an inspection was scheduled.

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Products

RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery System, manufactured by Accuray Incorporated, Sunnyvale, CA. Intended for use in the support
Brand
Accuray Inc
UPC
RoboCouch model 025007

Units Affected

26

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