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
    • G3
    • G4
    • VSI
  • 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
    • G3
    • G4
    • VSI
  • Serial numbers

    115 of 115 codes

    • C0023
    • C0030
    • C0045
    • C0046
    • C0047
    • C0006
    • C0012
    • C0040
    • C0048
    • C0049
    • C0013
    • C0011
    • C0052
    • C0055
    • C0022
    • C0053
    • C0042
    • C0057
    • C0017
    • C0059
    • C0056
    • C0060
    • C0062
    • C0061
    • C0067
    • C0068
    • C0070
    • C0041
    • C0063
    • C0065
    • C0074
    • C0071
    • C0079
    • C0078
    • C0080
    • C0064
    • C0090
    • C0024
    • C0087
    • C0091
    • C0095
    • C0094
    • C0092
    • C0093
    • C0097
    • C0098
    • C0099
    • C0100
    • C0101
    • C0102
    • C0103
    • C0106
    • C0089
    • C0108
    • C0107
    • C0105
    • C0112
    • C0114
    • C0118
    • C0119
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 9, 2017 · Data as of Sep 19, 5:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.