Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
This recall has been terminated (originally issued September 20, 2018).
- Company
- Accuray Incorporated
- Recall Initiated
- August 31, 2018
- Posted
- September 20, 2018
- Terminated
- December 16, 2020
- Recall Number
- Z-3211-2018
- Quantity
- 259 units
- Firm Location
- Madison, WI
- Official Source
- View on FDA website ↗
Reason for Recall
the Ball Cube II phantom calibration film was not manufactured within necessary dimensions and may introduce up to 0.5 mm of positional inaccuracy to the CyberKnife System
Distribution
Worldwide Distribution: United States (nationwide), and countries of: United Kingdom, Germany, France, Finland, Netherlands, Portugal, Hong Kong, Poland, Australia, United Arab Emirates, Thailand, and Japan.
Lot / Code Info
All units with the Ashland Brand distributed between August 1, 2017 and July 31, 2018
Root Cause
Nonconforming Material/Component
Action Taken
The firm, Accuray, disseminated their "Urgent Field Safety Notices" dated 08/31/2018 by email and letter to its customers. The letter described the product, problem and actions to be taken. The letter requested the customers cease use and quarantine the product for recovery and replacement by an Accuray Representative and complete and return the Acknowledgement Form via email at: astsauver@accuray.com or mail to: Accuray Incorporated, one Erdman place, Madison, WI 53719. If you have any questions, contact Vice President, Regulatory Affairs at 608-824-2800 or email: dbiank@accuray.com or the Regulatory Affairs Specialist at 408-716-4660 or jysingh@accuray.com.