CLASS II Device recall · Reported 26 Sep 2018 · FDA Enforcement Report

Ashland(TM) Box Film Ball Cube II EBT3 recalled by Accuray Incorporated

Accuray is recalling Ashland(TM) Box Film Ball Cube II EBT3, distributed nationwide in the US. The recall was initiated on 31 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll units with the Ashland Brand distributed between August 1, 2017 and July 31, 2018

Quantity recalled259 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3211-2018
FDA event ID: 80933
Recalling firm: Accuray, Madison, WI
Classification: Class II
Status: Terminated
Recall initiated: 31 Aug 2018
FDA classified: 20 Sep 2018
Reported: 26 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

31 Aug 2018	Recall initiated by company
20 Sep 2018	Classified by FDA	+20 days
26 Sep 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

All units with the Ashland Brand distributed between August 1, 2017 and July 31, 2018

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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