CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Radiolo
FDA device recall Z-0734-2017 · posted 2016-12-12 · Terminated
Recall details
- Recalling firm
- Accuray Incorporated
- Reason for recall
- Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. This issue is limited to certain CyberKnife Systems with software version 1 0.6.
- Action taken
- Accuray sent an Urgent Safety Advisory Notification letter dated November 22, 2016, to all affected customers. Letters alerted users to the issue and the sequence of events necessary for it to occur. Accuray reps will visit all sites to perform a software upgrade to correct the issue. For more information or any questions about this notification, please contact Accuray Customer Support at 1-877-668-8667 or visit the Accuray Technical Solution Center at http://www.accuray.com/services-support. For further questions, please call (408) 716-4600.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 40 affected devices
- Distribution
- Worldwide Distribution - US Distribution to the states of : PA, WA, MT, NY, SC, CA, MN, AK, NJ, FL, KY, WI., and to the countries of : Bulgaria, Canada, France, Germany, India, Japan, Luxembourg, Neth
- Date initiated
- 2016-11-22
- Date posted
- 2016-12-12
- Date terminated
- 2017-05-22
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM (K122137) | Accuray Incorporated | 2012-10-26 |