FDA-Device2019-05-08Class II
NM/CT 850 Product Usage: The GE NM/CT 850 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 component which is intended specifically for enabling attenuation correction and anatomical localization of SPECT images.
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
31 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
NM/CT 850 Product Usage: The GE NM/CT 850 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 component which is intended specifically for enabling attenuation correction and anatomical localization of SPECT images.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1262-2019Don't want to check this manually?
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