Reported Nov 26, 2014 · Terminated
CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife 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 System with the first generation IRIS Variable Aperture Collimator. The CyberKnife 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 number 054000-0001
- Serial numbersSerial #
C0141C0182C0225C0256C0137C0112C0244C0210C0160C0208C0118C0090C0207C0181C0034C0047C0197C0174C0101C0186C0178
Serial # C0192 C0055 C0072 C0061 C0134 C0177 C0247 International Sites Serial #C0198C0214C0059C0172C0068C0057C0263C0092C0199C0151C0179C0226C0158C0131C0144C0223C0071C0094C0183C0143
Serial #C0175C0189C0191C0215C0227C0187C0242C0185C0218C0237C0240C0265C0268C0251C0235C0229C0212C0239
C0043C0211C0255C0270C0176C0093C0234C0221C0249C0232C0180C0238C0231C0202C0230C0264C0266
- Amount recalled
- 84 devices subject to correction.
Where it was sold
Why it was recalled
Software upgrade to correct potential safety issue related to CyberKnife System that occurs when upgrading the Treatment Delivery Software for the first generation Iris Variable Aperture Collimator.
This product could cause temporary or reversible health problems — stop using it.
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