Z-3211-2018Class II

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

Name: Z-3211-2018 Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
Creator: Accuray Incorporated
Published: 2018-08-31
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2018-08-31 / Terminated / root cause: manufacturing process

FDA source

Accuray Incorporated began a recall of Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems on 2018-08-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3211-2018
Classification: Class II
Status: Terminated
Initiated: 2018-08-31
Posted: 2018-09-20
Terminated: 2020-12-16
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
Product code: IYE Accelerator, Linear, Medical
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
Root cause tag: manufacturing process
FDA 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: [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].
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.
Product codes and lots: All units with the Ashland Brand distributed between August 1, 2017 and July 31, 2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3211-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3211-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20

Product code IYE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)