Mirion Technologies (Capintec), Inc. - Captus - Class 2 Recall
Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. Models: 5430-30151, 5430-30152, and 5430-30154 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 10, 2024 Category: Medical Devices Source Type: alerts
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING - Class 1 Recall
GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3_8 NM Gantry, d) 860 / Dismount, e) 860 3_8 NM Gantry, f) 860 5_8 NM Gantry, g) 860 BJ, h) NM 830 3/8 BJ, i) NM/CT 850 3/8 BJ, j) NM/CT 850 3/8 ROW, k) NM/CT 850 3/8 ROW_, l) NM/CT 850 CT 850 3/8, m) NM/CT 850 ES 3/8, n) NM/CT 850 ES 3/8 ROW, o) NM/CT 860 3/8, p) NM/CT 860 3/8 BJ, q) NM/CT 860 3/8 ROW, r) NM/CT 860 ADVANCE, s) NM/CT 860 advance 3/8" NM Gantry, t) NM/CT 860 BEYOND, u) NM/CT 860 beyond 3/8" NM Gantry, v) NM/CT 860 China for China, w) NM/CT 860 CT 860 3/8, x) NM/CT 860 ES 3/8, y) NM/C...
Source: Medical Device Recalls - February 9, 2023 Category: Medical Devices Source Type: alerts
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING - Class 1 Recall
GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM_CT 870 CZT, i) NMCT 870 CZT O540+ 7.25MM; Emission Computed Tomography System (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 9, 2023 Category: Medical Devices Source Type: alerts
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING - Class 1 Recall
GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3_8 NM GANTRY WITH NEW ROTOR - MEA, c) 870 DR / Dismount, d) 870 DR / Dismount / 60HZ, e) 870 DR 3/8" WSO, f) 870 DR 3_8 NM Gantry, g) 870 DR 3-8, h) 870 DR 3-8 CH, i) 870 DR 5_8 NM GANTRY, j) 870 DR BJ / Dismount, k) 870 DR CyberDefense 3_8 NM Gantry, l) 870 DR NM GANTRY FINAL - NEW ROTOR, m) 870 DR China, n) D670 NM GANTRY WITH NEW ROTOR, o) D670 DR 3/8 16 SL, p) D670 DR 3/8 MEA, q) D670 DR 3-8, r) D670 DR 3-8 16SL, s) D670 DR 3-8 16SL NR, t) D670 DR 3-8 BJ, u) D670 DR 3-8 MEA, v) D670 DR NM Gantry 3-8, w) D670 DR NM G...
Source: Medical Device Recalls - February 9, 2023 Category: Medical Devices Source Type: alerts
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING - Class 1 Recall
GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640X3/8 NR, b) DISCOVERY O640X 3/8, c) NM OPTIMA O640X3/8, d) O640 NM Gantry 3-8, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640X3/8; Emission Computed Tomography System (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 9, 2023 Category: Medical Devices Source Type: alerts
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING - Class 1 Recall
GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50HZ, f) 830 / Dismount / 60HZ, g) 830 3/8 inch Detector, h) 830 BJ, i) 830 BJ / 5144407, j) 830 BJ / Dismount, k) 830 ES DEM, l) 830 NM Cyber Defense Configuration Gantry 3-8, m) 830 NM Gantry 3-8, n) 830 NM Gantry 5-8, o) 870 DR NM GANTRY FINAL - NEW ROTOR, p) B615 to D630 UPG, q) D630 NM GANTRY, r) D630 NM GANTRY 3_8 WITH NEW ROTOR - MEA, s) D630 NM Gantry 3-8, t) D630 NM GANTRY FINAL ASSEMBLY_, u) D630 with new rotor, v) D630 with new rotor/ 5144407 / Dismount, w...
Source: Medical Device Recalls - February 9, 2023 Category: Medical Devices Source Type: alerts
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING - Class 1 Recall
GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 DHP BJG NR, b) BRIVO 615 3/8, c) BRIVO B615 3/8 DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 BJG, f) BRIVO B615 3/8 DHP BJG NR, g) B615 with new rotor; Emission Computed Tomography System (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 9, 2023 Category: Medical Devices Source Type: alerts
Bayer Medical Care, Inc. - Class 2 Recall
Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (PET Positron Emission Tomography - nuclear medicine) diagnostic procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 7, 2023 Category: Medical Devices Source Type: alerts
Philips North America, LLC - JETStream Workspace - Class 2 Recall
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2021 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Optima NM/CT 640 - Class 2 Recall
Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2021 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Discovery NM - Class 2 Recall
Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2021 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - GE NM/CT 850 - Class 2 Recall
GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2021 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - GE NM/CT 860 - Class 2 Recall
GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2021 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - GE NM/CT 870 CZT - Class 2 Recall
GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2021 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Discovery 670DR - Class 2 Recall
Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such NM System: 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 imaging features designed to enhance image quality. (Sour...
Source: Medical Device Recalls - January 14, 2021 Category: Medical Devices Source Type: alerts
