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Terminated

CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.2 and higher.

FDA Recall Z-2056-2008 · Posted 2008-09-17

Recalling FirmAccuray Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2008-04-09
Date Terminated2010-11-30
Product Quantity109 units

Reason for Recall

Sample beam data (which should not be used to treat patients) may differ from actual radiation output of an installed product, and which may be used by users.

Firm Action

On April 16, 2008, the firm issued notifications via fedex to affected sites. In addition, installation and upgrade procedures will be updated to incorporate a step which decommissions sample beam data. If you have questions, contact Accuray Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or send and email to [email protected].

Root Cause

Software design

Distribution Pattern

Product was distributed to 104 medical centers throughout the US and to Vietnam, China, Korea, Taiwan, Malaysia, Turkey, France, Italy, Spain, Greece and Germany.

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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