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Terminated

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.

FDA Recall Z-0853-2011 · Posted 2011-01-11

Recalling FirmAccuray Inc
Recall StatusTerminated
Product CodeJAI
Date Initiated2009-07-21
Date Terminated2011-01-12
Product Quantity26

Reason for Recall

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

Firm Action

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

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution -- USA, including states of CA, FL, VA, AL, CT, MA, NC, TN, PA, RI, and NE and countries of Turkey, France, UK, Saudi Arabia, and Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072504CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEMAccuray Incorporated · 2007-09-21K042146ROBOCOUCH PATIENT SUPPORT SYSTEMAccuray Incorporated · 2004-09-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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