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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:146916

BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Official recall number

Z-2000-2016

Evidence summary

Product code
KPS
Recall status
Terminated
Event initiated
April 25, 2016
Root cause
Process design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2000-2016

Field note

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