Reported Dec 21, 2016 · Terminated
CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0…
Accuray Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accuray Incorporated · 1310 Chesapeake Ter · Sunnyvale, CA · 94089-1100
Is this the product you have?
- CyberKnife Robotic Radiosurgery System using software version 10.6
- Catalog/Part Number54000
- UDIM658053301 0
- RadiologyThe 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
- Lot codes and dates
- Catalog/Part Number54000
- manufacturing or serial number of UDIM658053301 0
- Serial numbers
C0330C0334C0336C0338C0342C0344C0348C0349C0351C0358C0359C0360C0361C0363C0364C0366C0367C0370C0372C0376C0387C0389C0390C0391C0393C0394C0395C0396C0397C0398C0400C0402C0404C0406C0407C0408C0409C0410C0413C0414
- Amount recalled
- 40 affected devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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