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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:142244

RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms

Official recall number

Z-0647-2016

Evidence summary

Product code
MUJ
Recall status
Terminated
Event initiated
November 05, 2015
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0647-2016

Field note

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