CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System, manufactured by Accuray
FDA device recall Z-1810-2009 · posted 2009-09-14 · Terminated
Recall details
- Recalling firm
- Accuray Inc
- Reason for recall
- Targeting accuracy out of specification, Error alert does not render the system down, which may result in mistreatment in the wrong area.
- Action taken
- Accuray, Inc. issued an "Urgent Device Correction" notice dated June 22, 2009. The consignees were informed of the defect including methods for detecting the error. The firm is in the process of developing a software patch to address the issue. For further information, contact Accuray, Inc. Customer Support at +1-877-668-8667 (US) or +1-408-716-4700 (outside US) or customersupport@accuray.com.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 61 units
- Distribution
- Worldwide Distribution -- US including states of MA, FL, AL, TN, DE, CA, NJ, OK, CO, NC, IL, PA, MD, DC, MS, CN, NV, RI, SC, UT, VA, MI, NE, MO, TX and AL and countries of Canada, Russia, UK, Ukraine,
- Date initiated
- 2009-06-22
- Date posted
- 2009-09-14
- Date terminated
- 2011-01-05
- 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 |
|---|---|---|
| CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K072504) | Accuray Incorporated | 2007-09-21 |