Reported Dec 28, 2016 · Terminated
CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic Radiosurgery System is…
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 Systems
- models
G3G4VSI
- 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
- models
G3G4VSI
- Serial numbers
115 of 115 codes
C0023C0030C0045C0046C0047C0006C0012C0040C0048C0049C0013C0011C0052C0055C0022C0053C0042C0057C0017C0059C0056C0060C0062C0061C0067C0068C0070C0041C0063C0065C0074C0071C0079C0078C0080C0064C0090C0024C0087C0091C0095C0094C0092C0093C0097C0098C0099C0100C0101C0102C0103C0106C0089C0108C0107C0105C0112C0114C0118C0119
- models
- Amount recalled
- 115 affected devices.
Where it was sold
Why it was recalled
Accuray has become aware of a potential safety issue involving the possibility of electric shock during maintenance activities from the lon Pump HV Power Supply at the back of the modulator cabinet. This issue is limited to certain G3, G4, and VSI models of the CyberKnife¿ Robotic Radiosurgery System.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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