# K022960: GE Quasar Nuclear Medicine System - Pathway: 510(k) (Traditional) - Applicant: Ge Medical Systems F.I. Haifa - Decided: Sep 19, 2002 after 13 days - Product code: KPS (System, Tomography, Computed, Emission) - Device class: 2 - Regulation: 21 CFR 892.1200 - Recalls of this device: 24 (1 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 3 generations back to K952674 (1995). 5 ancestors in all. 23 later devices descend from it; 4 cite it directly. 9 of 29 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K953801: Varicam, Elscint, Inc. (1995) Summary page 1. - K991841: Hawkeye Option for Dual-Head Variable Angle Gamma Camera, Ge Medical Systems F.I. Haifa (1999) Summary page 1. - K962100: Volmetric Coincidence Detection System, Elscint, Inc. (1997) Summary page 1. ## Most influential descendants - K093514: Discovery Model NM/CT 670 (2009), 13 descendants of its own - K153402: Discovery NM/CT 670 CZT (2016), 6 descendants of its own - K182484: VERITON CT whole body SPECT/CT system (2018), 3 descendants of its own - K102231: Discovery NM 750B (2010), 3 descendants of its own - K051855: Ventri (2005), 3 descendants of its own ## Recalls of this device - Jun 20, 2025 · Class II · Z-2097-2025: Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in l - Dec 18, 2024 · Class II · Z-0888-2025: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details an - Dec 18, 2024 · Class II · Z-0897-2025: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details an - Dec 18, 2024 · Class II · Z-0898-2025: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details an - Dec 18, 2024 · Class II · Z-0899-2025: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details an - Oct 14, 2014 · Class II · Z-0185-2015: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. - Oct 14, 2014 · Class II · Z-0186-2015: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. - Oct 14, 2014 · Class II · Z-0188-2015: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. - Oct 14, 2014 · Class II · Z-0189-2015: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. - Oct 14, 2014 · Class II · Z-0187-2015: GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems. This check is being add - Oct 14, 2014 · Class II · Z-0184-2015: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. - Feb 7, 2014 · Class II · Z-1198-2014: Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in wh - Feb 7, 2014 · Class II · Z-1200-2014: Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in wh - Feb 7, 2014 · Class II · Z-1199-2014: Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in wh - Jun 13, 2013 · Class I · Z-1787-2013: GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. - Mar 6, 2012 · Class II · Z-1078-2013: Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may impact patient and ope - Sep 8, 2008 · Not classified · Z-1095-2009: There is a possibility for misregistration when brain scans are performed with Infinia with the Hawkeye option. This misregistration could present the potential for misdiagnosis when the patient headr - Sep 8, 2008 · Not classified · Z-1094-2009: There is a possibility for misregistration when brain scans are performed with Infinia with the Hawkeye option. This misregistration could present the potential for misdiagnosis when the patient headr - Jun 2, 2008 · Not classified · Z-1001-2009: GE Healthcare has recently became aware of excessive pressure applied by the collimator pressure sensitive cover of Infinia (Infinia, Infinia Hawkeye, Infinia Hawkeye 4) that may impact patient safety - Jun 2, 2008 · Not classified · Z-1003-2009: GE Healthcare has recently became aware of excessive pressure applied by the collimator pressure sensitive cover of Infinia (Infinia, Infinia Hawkeye, Infinia Hawkeye 4) that may impact patient safety - Jun 2, 2008 · Not classified · Z-1002-2009: GE Healthcare has recently became aware of excessive pressure applied by the collimator pressure sensitive cover of Infinia (Infinia, Infinia Hawkeye, Infinia Hawkeye 4) that may impact patient safety - Jun 2, 2008 · Not classified · Z-1121-2009: The metal pin in the adjustable head holder, which is used to acquire Brain SPECT data on Infinia systems (Infinia, Infinia Hawkeye, and Infinia Hawkeye 4), creates an artifact on the patient's cerebe - Jun 2, 2008 · Not classified · Z-1120-2009: The metal pin in the adjustable head holder, which is used to acquire Brain SPECT data on Infinia systems (Infinia, Infinia Hawkeye, and Infinia Hawkeye 4), creates an artifact on the patient's cerebe - Jun 2, 2008 · Not classified · Z-1119-2009: The metal pin in the adjustable head holder, which is used to acquire Brain SPECT data on Infinia systems (Infinia, Infinia Hawkeye, and Infinia Hawkeye 4), creates an artifact on the patient's cerebe ## Indications for use The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT , Gated SPECT , Whole body SPECT , Camera based PET - also known as Coincidence Detection). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping. Source page: https://510kreport.com/device/K022960 Methodology: https://510kreport.com/methodology