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Terminated

Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems

FDA Recall Z-3211-2018 · Posted 2018-09-20

Recalling FirmAccuray Incorporated
Recall StatusTerminated
Product CodeIYE
Date Initiated2018-08-31
Date Terminated2020-12-16
Product Quantity259 units

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

Firm 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: [email protected] 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: [email protected] or the Regulatory Affairs Specialist at 408-716-4660 or [email protected].

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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