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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:114846

Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

Official recall number

Z-0883-2013

Evidence summary

Product code
KPS
Recall status
Terminated
Event initiated
October 24, 2012
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0883-2013