CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic
FDA device recall Z-0771-2016 · posted 2016-02-09 · Terminated
Recall details
- Recalling firm
- Accuray Incorporated
- Reason for recall
- The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a patient.
- Action taken
- Accuray sent an Urgent Safety Advisory Notification letters dated January 22, 2016 to all affected customers by trackable mail method. The letters identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Acknowledgement form. For questions contact Customer Support at 1-877-668-8667 or visit the Accuray Technical Solution Center at http://www.accuray.com/services-support
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 226
- Distribution
- Worldwide Distribution. US Nationwide, Venezuela, United Kingdom, Ukraine, Turkey, Thailand, Taiwan, Switzerland, Spain, Saudi Arabia, Russia, Poland, Pakistan, Myanmar, Mexico, Korea, Japan, Italy, I
- Date initiated
- 2016-01-22
- Date posted
- 2016-02-09
- Date terminated
- 2016-10-20
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNCHRONY RESPIRATORY TRACKING SYSTEM (K120233) | Accuray Incorporated | 2012-03-09 |