Z-1126-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2013
- Initiation Date
- March 19, 2013
- Termination Date
- October 23, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 176 units
Product Description
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.
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 Pattern
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.
Code Information
All units of these models.