Z-1126-2013Class II

Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation...

Name: Z-1126-2013 Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation...
Creator: Accuray Incorporated
Published: 2013-03-19
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2013-03-19 / Terminated / root cause: design

FDA source

Accuray Incorporated began a recall of Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture... on 2013-03-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1126-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-19
Posted: 2013-04-16
Terminated: 2013-10-23
Recalling firm: Accuray Incorporated
Product: 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 code: IYE Accelerator, Linear, Medical
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 3/19/13, an "Urgent Device Correction Letter" was distributed to all affected users, with a description of the problem and user corrective action steps. US customers can contact 1-877- 668-8667 if questions.
Quantity in commerce: 176 units
Distribution: 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.
Product codes and lots: All units of these models.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1126-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1126-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-16

Product code IYE

K122137Class IICyberknife Robotic Radiosurgery System Cyberknife Vsi Robotic Radiosurgery SystemAccuray Incorporated / cleared 2012-10-26

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)