Z-0890-2011

CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System radiation...

Name: Z-0890-2011 CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System radiation...
Creator: Accuray Inc
Published: 2010-07-06
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2010-07-06 / Terminated / root cause: design

FDA source

Accuray Inc began a recall of CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System radiation therapy device, manufactured by Accuray Inc... on 2010-07-06. The reason FDA records is "Latches responsible for securing the cover to the device may come lose if not properly secured and the cover may unexpectedly drop off. A design change is planned". 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-0890-2011
Status: Terminated
Initiated: 2010-07-06
Posted: 2011-01-10
Terminated: 2011-10-04
Recalling firm: Accuray Incorporated
Product: CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System radiation therapy device, manufactured by Accuray Inc., Sunnyvale, CA. Medical device indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Latches responsible for securing the cover to the device may come lose if not properly secured and the cover may unexpectedly drop off. A design change is planned.
Root cause tag: design
FDA root cause: Device Design
Action: Accuray sent an "URGENT DEVICE CORRECTION" letter dated July 6, 2010, to all customers. The letter described the product, problem and actions to be taken by customers. The customers were instructed to assure the LINAC cover is secure following reattachment and adhere to and follow the instructions included in the letter. Note: A new design is being developed, and will be distributed to user base once available. If you have any questions or concerns regarding this issue, please do not hesitate to contact Accuray Customer Support at +1-877-668-8667 (USA) or +1-408-716-4700 (non-USA) or [email protected].
Quantity in commerce: 207 units
Distribution: Worldwide distribution: US including: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI and WV, and countries including: Japan, China, Vietnam, Taiwan/China, South Korea, Hong Kong/China, Thailand and Malaysia.
Product codes and lots: All products are affected.

Product code MUJ

K091146Class IIModification to Cyberknife Robotic Radiosurgery SystemAccuray, Inc. / cleared 2009-05-01

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)