Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. GE Healthcare, LLC - Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE - Class 2 Recall Vortex TR, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816 These devices are not intended for mammography applications.Īngiodynamics, INC - Vortex TR - Class 2 Recall They are intended to replace fluoroscopic images obtained through image intensifier technology. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures.
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The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures. Innova 2121-IQ/3131-1Q Biplane Cardiovascular Imaging System. GE Healthcare, LLC - Innova 2121IQ/31311Q Biplane Cardiovascular Imaging System - Class 2 Recall Vortex LP, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816 Those devices are not intended for mammography applications.Īngiodynamics, INC - Vortex LP - Class 2 Recall
They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Triumph-1, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816. Those devices are not intended for mammography applicationsĪngiodynamics, INC - Triumph1 - Class 2 Recall Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. GE Healthcare, LLC - Innova 2100IQ (The Digital Fluoroscopic Imaging System) - Class 2 Recall LifePort, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816. Vortex VX Port, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816Īngiodynamics, INC - LifePort - Class 2 Recall Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, Inc 6001-A Gulf Freeway, Houston, Texas 77023Īngiodynamics, INC - Vortex VX Port - Class 2 Recall Millar Instruments, Inc - Millar MikroTip Disposable Angiographic Catheter (Left Heart) - Class 2 Recall Intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8" SPECT, Model number 451 and 5/8" SPECT, Model number 451, manufactured by Philips Medical Systems (Cleveland), Cleveland OH. Philips Medical Systems - SKYLight Gamma Camera - Class 2 Recall I-STAT ACT Celite Cartridges in vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples. iSTAT ACT Celite Cartridges - Class 2 Recall I-STAT ACT Kaolin Cartridges in vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.Ībbott Point Of Care Inc. iSTAT ACT Kaolin Cartridges - Class 2 Recall