Z-0382-2012

CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option. The CyberKnife treatment is...

Name: Z-0382-2012 CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option. The CyberKnife treatment is...
Creator: Accuray Incorporated
Published: 2011-11-07
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2011-11-07 / Terminated / root cause: labeling and UDI

FDA source

Accuray Incorporated began a recall of CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option. The CyberKnife treatment is indicated for the treatment planning and image guided... on 2011-11-07. The reason FDA records is "User Facility reported an anomaly where inhale and exhale CT pairs used for treatment planning did not represent the same magnitude of respiration that was displayed during treatment delivery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0382-2012
Status: Terminated
Initiated: 2011-11-07
Posted: 2012-01-11
Terminated: 2012-02-27
Recalling firm: Accuray Incorporated
Product: CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option. The CyberKnife treatment is indicated for the treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: User Facility reported an anomaly where inhale and exhale CT pairs used for treatment planning did not represent the same magnitude of respiration that was displayed during treatment delivery.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Accuray sent a Urgent Medical Device Correction letter dated November 7, 2011, via Federal Express to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The information provided in this letter will be incorporated in user manuals shipped with the CyberKnife system. 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) 1. (408) 716-4700 ( non USA )
Quantity in commerce: 30
Distribution: Worldwide Distribution -- USA ( nationwide ) including the states of FL, TN, IL, NJ, CO, PA, MD, CA, MS, MN, SC, WA, OK, GA, AZ, and TX., and the countries of France and United Kingdom.
Product codes and lots: Model number: PN 032384

Product code IYE

K091999Class IICyberknife Robotic Radiosurgery SystemAccuray, Inc. / cleared 2009-09-18

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)