Z-0734-2017Class II

CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI...

Name: Z-0734-2017 CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI...
Creator: Accuray Incorporated
Published: 2016-11-22
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2016-11-22 / Terminated / root cause: software

FDA source

Accuray Incorporated began a recall of CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Radiology: The CyberKnife Robotic Radiosurgery... on 2016-11-22. FDA classified it as Class II and gives the reason as "Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. This issue is limited to certain CyberKnife Systems with software version 1 0.6". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0734-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-22
Posted: 2016-12-12
Terminated: 2017-05-22
Recalling firm: Accuray Incorporated
Product: CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. This issue is limited to certain CyberKnife Systems with software version 1 0.6.
Root cause tag: software
FDA root cause: Software design
Action: Accuray sent an Urgent Safety Advisory Notification letter dated November 22, 2016, to all affected customers. Letters alerted users to the issue and the sequence of events necessary for it to occur. Accuray reps will visit all sites to perform a software upgrade to correct the issue. For more information or any questions about this notification, please contact Accuray Customer Support at 1-877-668-8667 or visit the Accuray Technical Solution Center at http://www.accuray.com/services-support. For further questions, please call (408) 716-4600.
Quantity in commerce: 40 affected devices
Distribution: Worldwide Distribution - US Distribution to the states of : PA, WA, MT, NY, SC, CA, MN, AK, NJ, FL, KY, WI., and to the countries of : Bulgaria, Canada, France, Germany, India, Japan, Luxembourg, Netherlands, Portugal, Switzerland and Turkey
Product codes and lots: Catalog/Part Number: 54000 manufacturing or serial number of UDI: M658053301 0; Serial numbers: C0330 C0334 C0336 C0338 C0342 C0344 C0348 C0349 C0351 C0358 C0359 C0360 C0361 C0363 C0364 C0366 C0367 C0370 C0372 C0376 C0387 C0389 C0390 C0391 C0393 C0394 C0395 C0396 C0397 C0398 C0400 C0402 C0404 C0406 C0407 C0408 C0409 C0410 C0413 C0414

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0734-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0734-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-12

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)