Accuray Recalls CyberKnife Systems Due to Unexpected Robot Motion
Accuray is recalling 40 CyberKnife Robotic Radiosurgery Systems with software version 10.6 due to a potential safety issue involving unexpected treatment robot motion when removing an accessory.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device with a potential for physical injury (unexpected robot motion), but the source text does not report any actual injuries or illnesses, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Accuray Incorporated is recalling 40 CyberKnife Robotic Radiosurgery Systems equipped with software version 10.6. The recall is due to a potential safety issue where the treatment robot may exhibit unexpected motion when an accessory is removed. The affected devices are identified by Catalog/Part Number 54000 and UDI M658053301 0.
The affected units were distributed worldwide, including in the United States and various international locations. The source text does not report any illnesses, injuries, or deaths associated with this issue. The hazard is limited to the specific software version and the mechanical action of removing an accessory.
The recalled product
- 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 fo
- Manufacturer
- Accuray Incorporated
- Hazard
- Affected units
- 40
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog/Part Number: 54000 manufacturing or serial number of UDI: M658053301 0
Distribution
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