Device product
Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT 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, cardiac and vascular X-ray Computed Tomography applications.
Z-1258-2019
Product summary
- Event
- Event 82582
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-1258-2019
Official wording
Reason: 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.
Code information: Mfg. Lot or Serial # System ID AD7X38019 250727D670 AD7X38022 C5323544 AD7X38020 00433NUC11
Distribution pattern: US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK
Derived failure modes
-
Unknown
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.