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Terminated

Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation therapy device. Model number 020700 (axum/standard treatment couch) and 021756 hand controller. The device is indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

FDA Recall Z-1862-2008 · Posted 2008-09-16

Recalling FirmAccuray Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2008-05-01
Date Terminated2010-11-30
Product Quantity105 units

Reason for Recall

Couch may move unexpectedly, which may result in patient impacting the linear accelerator.

Firm Action

All affected sites were notified via customer advisory notice. The Standard Treatment couch firmware will be updated and all affected sites will be retrofitted. Contact Customer Service at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or [email protected] for additional information.

Root Cause

Software design

Distribution Pattern

Product was distributed throughout the US and to China, Taiwan, Korea, Italy, Malaysia, Germany, Netherlands, Vietnam, Greece, Spain, and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072504CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEMAccuray Incorporated · 2007-09-21

Official Source

View FDA Recall →

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

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