CyberKnife Robotic Radiosurgery System: Lung Optimized… recallZ-0382-2012 · Accuray Incorporated · initiated Nov 7, 2011
Terminated All recalls posted in January 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Accuray Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling design
What the company is doing
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 )
Recall details
- Recall number
- Z-0382-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 7, 2011
- Posted by the FDA
- Jan 11, 2012
- Recalling firm
- Accuray Incorporated
- Quantity
- 30
- Product code
- IYE
- FDA submissions
- K091999
- 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 description
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.
Code information (models, lots, serial numbers)
Model number: PN 032384
Other devices under the same FDA submission
1 device cleared under K091999 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CyberKnife® VSI™ System 032500-M-000Accuray Incorporated · Accelerator, Linear, Medical1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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