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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:168358

CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are 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.

Official recall number

Z-0408-2019

Evidence summary

Product code
IYE
Recall status
Terminated
Event initiated
September 26, 2018
Root cause
Process control
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-0408-2019

Field note

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