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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:163344

ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.

Official recall number

Z-1401-2018

Evidence summary

Product code
IYE
Recall status
Terminated
Event initiated
February 14, 2018
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1401-2018

Field note

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