Accuray Incorporated: Medical Device Recall in 2018 - (Recall #: Z-3211-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 31, 2018

Date Posted: September 26, 2018

Recall Number: Z-3211-2018

Event ID: 80933

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

Status: Terminated

Product Quantity: 259 units

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated