Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.
This recall has been terminated (originally issued April 16, 2013).
- Company
- Accuray Incorporated
- Recall Initiated
- March 19, 2013
- Posted
- April 16, 2013
- Terminated
- October 23, 2013
- Recall Number
- Z-1126-2013
- Quantity
- 176 units
- Firm Location
- Sunnyvale, CA
- Official Source
- View on FDA website ↗
Reason for Recall
A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings, resulting in a potential shift to the central axis of the radiation beam. The issue could pose significant clinical impact to plans created using the smallest collimators.
Distribution
Worldwide distribution, including Nationwide in the US and the countries of Korea, Myanmar, Canada, Belgium, England, Czech Republic, Finland, France, Germany, Greece, India, Italy, Poland, Russia, Spain, Switzerland, Turkey, Columbia, Mexico, Japan and Saudi Arabia.
Lot / Code Info
All units of these models.
Root Cause
Component design/selection
Action Taken
On 3/19/13, an "Urgent Device Correction Letter" was distributed to all affected users, with a description of the problem and user corrective action steps. US customers can contact 1-877- 668-8667 if questions.