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U.S. Department of Health and Human Services

Class 2 Device Recall Ashland(TM) Box Film Ball Cube II EBT3

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  Class 2 Device Recall Ashland(TM) Box Film Ball Cube II EBT3 see related information
Date Initiated by Firm August 31, 2018
Date Posted September 20, 2018
Recall Status1 Terminated 3 on December 16, 2020
Recall Number Z-3211-2018
Recall Event ID 80933
Product Classification Accelerator, linear, medical - Product Code IYE
Product Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E

Product is used to calibrate CyberKnife systems
Code Information All units with the Ashland Brand distributed between August 1, 2017 and July 31, 2018
Recalling Firm/
Accuray Incorporated
1240 Deming Way
Madison WI 53717-1954
For Additional Information Contact regional support
Manufacturer 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
FDA Determined
Cause 2
Nonconforming Material/Component
Action 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.
Quantity in Commerce 259 units
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.