Device evidence

device-recall:cfres:128391

GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

Official recall number

Z-2037-2014

Evidence summary

Product code: KPS
Recall status: Terminated
Event initiated: June 18, 2014
Root cause: Software design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2037-2014