255 results
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Sources: EU EUDAMED, US FDA
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GE Innova 2100IQ Versatile Cardiac and Vascular 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 product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
FDA Recall
Terminated
·GE Healthcare·Product code MQB·June 24, 2008
Toshiba America Medical Systems Inc (TAMS) Digital Radiography System Radrex-i DRAD-3000E; Electrostatic x-ray imaging system
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code MQB·May 22, 2009
EOS System X- ray beam Digital radiography system used in general radiographic examinations.
FDA Recall
Terminated
·Product code MQB·November 7, 2013
25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
FDA Recall
Terminated
·Synergetics Inc·Product code HQB·December 9, 2013
23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
FDA Recall
Terminated
·Synergetics Inc·Product code HQB·December 9, 2013
29ga Oshima Dual Chandelier, Synergetics, inc., length 7.5 ft, sterile / EO, 56.50.29P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
FDA Recall
Terminated
·Synergetics Inc·Product code HQB·December 9, 2013
Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code MQB·May 12, 2014
NX is the radiographer's image identification and quality control tool. It offers a broad array of features developed especially to meet the needs of the radiographer. Standard tasks are completed quickly and effortlessly with a simple touch screen. In-room integration provides a more convenient workflow for the radiographer throughout the imaging process. NX communicates seamlessly with the hospital's picture archiving and communication system (PACS), radiology information system (RIS) and hospital information system (HIS). It is DICOM compliant and meets IHE guidelines.
FDA Recall
Terminated
·AGFA Corp.·Product code MQB·March 4, 2011
GE Healthcare, Innova 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System. Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging-procedures.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code MQB·August 24, 2011
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code MQB·August 14, 2012
RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
FDA Recall
Terminated
·Virtual Imaging, Inc.·Product code MQB·November 2, 2018
DigitalDiagnost 4.1 (Stitching Patient Support) 712225
FDA Recall
Terminated
·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code MQB·June 27, 2018
DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
FDA Recall
Terminated
·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code MQB·June 27, 2018
Innova 2000's principle system components include a C-arm, image acquisition, processing and archiving capabilities.
FDA Recall
Terminated
·GE Healthcare·Product code MQB·January 14, 2008
Innova 2100IQ is a Digital Fluoroscopic Imaging System that consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector.
FDA Recall
Terminated
·GE Healthcare·Product code MQB·January 14, 2008
GE Innova 4100 / 4100 IQ. , 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 product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
FDA Recall
Terminated
·GE Healthcare·Product code MQB·June 24, 2008
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) Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology.
FDA Recall
Terminated
·GE Healthcare·Product code MQB·July 25, 2008
Innova 4100 / 4100 IQ , 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) Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology.
FDA Recall
Terminated
·GE Healthcare·Product code MQB·July 25, 2008
GE Healthcare Innova 4100 Digital Fluoroscopic Imaging System with Bolus Chasing option.
FDA Recall
Terminated
·GE Healthcare·Product code MQB·October 21, 2007
Innova 2000, manufactured by GE Medical Systems, SCS
FDA Recall
Terminated
·GE Healthcare, LLC·Product code MQB·June 10, 2010