Recall Z-0734-2017— Accuray Incorporated
Class II · Terminated
Class II FDA medical device recall by Accuray Incorporated, initiated 2016-11-22, terminated 2017-05-22. It names one FDA 510(k) clearance: K122137. Product: CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.. Reason: 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..
- Recalling firm
- Accuray Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-22
- Terminated
- 2017-05-22
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.