Accuray Incorporated: Medical Device Recall in 2013 - (Recall #: Z-1126-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.

Product Classification:

Class II

Date Initiated: March 19, 2013

Date Posted: April 24, 2013

Recall Number: Z-1126-2013

Event ID: 64712

Reason for Recall:

A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings, resulting in a potential shift to the central axis of the radiation beam. The issue could pose significant clinical impact to plans created using the smallest collimators.

Status: Terminated

Product Quantity: 176 units

Code Information:

All units of these models.

Distribution Pattern:

Worldwide distribution, including Nationwide in the US and the countries of Korea, Myanmar, Canada, Belgium, England, Czech Republic, Finland, France, Germany, Greece, India, Italy, Poland, Russia, Spain, Switzerland, Turkey, Columbia, Mexico, Japan and Saudi Arabia.

Voluntary or Mandated:

Voluntary: Firm initiated