CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System radiation therapy device
FDA device recall Z-0890-2011 · posted 2011-01-10 · Terminated
Recall details
- Recalling firm
- Accuray Inc
- 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.
- Action taken
- 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 customersupport@accuray.com.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 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 i
- Date initiated
- 2010-07-06
- Date posted
- 2011-01-10
- Date terminated
- 2011-10-04
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K091146) | Accuray, Inc. | 2009-05-01 |