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Recall Observatory FDA recall evidence

Device product

Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

Z-2085-2015

April 01, 2015

Class II

Product summary

Firm
Viewray Incorporated
Event
Event 71555
Status
Terminated
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-2085-2015

Official wording

Reason: ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.

Code information: Model #10000, Serial #'s: 100, 101, and 102

Distribution pattern: US Nationwide Distribution in the states of CA, MO & WI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.