Reported Feb 5, 2014 · Terminated
Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning…
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?
- Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
- Lot codes and dates
- Part number054000-001
- Serial numbers in US
144 of 144 codes
C0022C0030C0037C0042C0045C0046C0047C0048C0049C0051C0052C0053C0055C0056C0057C0058C0059C0061C0062C0063C0064C0067C0068C0070C0071C0072C0074C0078C0079C0080C0088C0090C0091C0092C0094C0095C0097C0098C0099C0100C0101C0102C0103C0106C0108C0109C0111C0112C0114C0118C0119C0122C0123C0126C0127C0128C0131C0132C0133C0134
- C0335 C0336 C0338 C0343 C0124 Out of USTBD
C0202C0231C0238C0351C0170C0171C0235C0267C0282
143 of 143 codes
C0032C0054C0060C0093C0105C0110C0113C0115C0117C0125C0130C0154C0161C0175C0176C0180C0185C0187C0188C0189C0191C0195C0204C0211C0215C0216C0217C0218C0221C0227C0228C0230C0232C0234C0236C0237C0240C0242C0245C0249C0251C0255C0264C0265C0266C0268C0269C0270C0272C0275C0276C0277C0279C0286C0287C0288C0292C0294C0295C0299
- Amount recalled
- 302 devices; 149 in US, 153 out of US.
Where it was sold
- Nationwide
Why it was recalled
Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.
This product could cause temporary or reversible health problems — stop using it.
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