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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:117103

GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration

Official recall number

Z-1164-2013

Evidence summary

Product code
LLZ
Recall status
Terminated
Event initiated
October 06, 2011
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1164-2013

Field note

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