Recall Z-1862-2008
Accuray Inc · initiated May 1, 2008
Product
Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation therapy device. Model number 020700 (axum/standard treatment couch) and 021756 hand controller. The device is indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Codes / lots: All models.
Reason for recall
Couch may move unexpectedly, which may result in patient impacting the linear accelerator.
FDA-determined cause: Software design
Action taken
All affected sites were notified via customer advisory notice. The Standard Treatment couch firmware will be updated and all affected sites will be retrofitted. Contact Customer Service at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or customersupport@accuray.com for additional information.
Details
- Recall number
- Z-1862-2008
- Initiated
- May 1, 2008
- Posted by FDA
- September 16, 2008
- Terminated
- November 30, 2010
- Product code
- IYE – Accelerator, Linear, Medical
- Quantity
- 105 units
- Distribution
- Product was distributed throughout the US and to China, Taiwan, Korea, Italy, Malaysia, Germany, Netherlands, Vietnam, Greece, Spain, and Puerto Rico.
- Recalling firm
- Accuray Inc, Sunnyvale, CA