FDA Medical Device Recalls (openFDA)
Accuray Incorporated: Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
- Recall number
- Z-3211-2018
- Recalling firm
- Accuray Incorporated
- Product
- Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
- Status
- Terminated
- Initiated
- 2018-08-31
- Posted
- 2018-09-20
- Terminated
- 2020-12-16
- Reason
- 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
- Root cause
- 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
- 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.
- Lot, serial or model codes
- All units with the Ashland Brand distributed between August 1, 2017 and July 31, 2018
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3003873069
- Firm city
- Madison
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28