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

FDA device recall Z-3211-2018 · posted 2018-09-20 · Terminated

Recall details

Recalling firm

Accuray Incorporated

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

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

IYE

Quantity affected

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

Date initiated

2018-08-31

Date posted

2018-09-20

Date terminated

2020-12-16

Location

Madison, WI