CLASS II Device recall · Reported 24 Apr 2013 · FDA Enforcement Report

CyberKnife System Medical Physicist recalled by Accuray Incorporated

Accuray is recalling CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical, distributed nationwide in the US. The recall was initiated on 19 Mar 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll units of these models.

Quantity recalled176 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-1126-2013
FDA event ID: 64712
Recalling firm: Accuray, Sunnyvale, CA
Classification: Class II
Status: Terminated
Recall initiated: 19 Mar 2013
FDA classified: 16 Apr 2013
Reported: 24 Apr 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

19 Mar 2013	Recall initiated by company
16 Apr 2013	Classified by FDA	+28 days
24 Apr 2013	Published in enforcement report	+8 days

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

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All units of these models.

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.

More recalls from Accuray

All 22

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide
8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide
5 Feb 2025Device	CLASS II	CyberKnife Treatment Delivery System recalled by Accuray Incorporated	Accuray	Other	Nationwide
6 Sep 2023Device	CLASS II	Upper roller bracket recalled by Accuray Incorporated	Accuray	Device Malfunction	Nationwide
24 Mar 2021Device	CLASS II	CyberKnife Treatment Delivery System recalled by Accuray Incorporated	Accuray	Other	Nationwide

Other Other Medical Devices recalls

All 13,884

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	NOxBOXi Nitric Oxide Delivery System recalled	Noxbox	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Palacos R pro recalled by Heraeus Medical GmbH (Dental	Heraeus Medical GmbH (Dental Division)	Packaging Defects	Nationwide
7 Oct 2026Device	CLASS II	Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled	Percussionaire	Other	Nationwide
7 Oct 2026Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire	Percussionaire	Other	Nationwide