FDA-Device2019-05-08Class II
NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body and vascular X-ray Comp
GE Healthcare, LLC
Hazard
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
Sold states
US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK
Affected count
6 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body and vascular X-ray Computed Tomography applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1263-2019Don't want to check this manually?
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