ACCURAY INC
CYBERKNIFE · General Hospital
510(k) Clearances (8)
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Recalls (10)
If users modify the dose calculation box to cover just the contoured anatomy and not the entire CT volume, dosage may not be properly calculated.
Latches responsible for securing the cover to the device may come lose if not properly secured and the cover may unexpectedly drop off. A design change is planned.
If electron density values are left empty, the calculation of radiation dose in a patient will be modeled as air-like density material rather than correct density. A plan may be created and saved, thus creating the risk of mistreatment.
Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches.
Targeting accuracy out of specification, Error alert does not render the system down, which may result in mistreatment in the wrong area.
The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with users or patients may result in serious injury if the boom descends unexpectedly.
The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with users or patients may result in serious injury if the boom descends unexpectedly.
System may use random incorrect data to calculate dose. Resulting dose calculation error can exceed 100% of correct dose which may lead to serious patient injury.
Product may not be tensioned properly, potentially causing unexpected rotation or descent.
Couch may move unexpectedly, which may result in patient impacting the linear accelerator.
MAUDE Adverse Events (10)
FDA Classification (66)
General Hospital
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