CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option. The CyberKnife treatment is indicated for the t
FDA device recall Z-0382-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Accuray Incorporated
- 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.
- Action taken
- 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 )
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 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.
- Date initiated
- 2011-11-07
- Date posted
- 2012-01-11
- Date terminated
- 2012-02-27
- Location
- Sunnyvale, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K091999) | Accuray, Inc. | 2009-09-18 |