228 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
EasyDiagnost Eleva x-ray systems
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·December 10, 2008
Electrophysiology Imaging System
FDA Recall
Terminated
·Fischer Imaging Corporation·Product code JAA·April 28, 2005
Electrophysiology Imaging System
FDA Recall
Terminated
·Fischer Imaging Corporation·Product code JAA·April 28, 2005
OEC 9900 Elite (NAV) Image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·March 1, 2007
OEC 9800 MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·March 1, 2007
GE Healthcare Precision RXi version e Remote X-Ray Imaging R&F System. It is a remote analog R&F system consisting of a tilting table with integrated spot film device, and 50KW or 65 kW pulsing generator. The system is configured with a 23 cm image intensifier and a 512x512 Image Chain.
FDA Recall
Terminated
·GE Healthcare·Product code JAA·December 18, 2007
Toshiba Infinix-i, INFX-8000F The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAA·December 21, 2010
AXIOM Artis and AXIOM Artis zee modular angiographic systems Product Usage: Angiographic x-ray systems
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAA·January 16, 2012
Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII Product Usage: The systems are intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations on both adult and pediatric subjects. The systmes are used for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAA·November 8, 2013
SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including but not limited to: Querying and retrieving patient history information and/or previous diagnosis and images from other modalities, including X-ray examinations of the urogenital area, Ultrasound examinations, Endourological interventions, Percutaneous interventions, Laparoscopy, Application of fistula, Simple procedures, Extracorporeal shock wave lithotripsy, Uroflow/urodynamics, Pediatric radiological and therapeutic applications.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAA·April 13, 2015
Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000 is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and transmission/output or images to external devices.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAA·January 14, 2016
Prestige SI
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAA·November 21, 2016
THREAD RETRIEVAL DRILL REF 2224
FDA Recall
Terminated
·Zimmer Dental Inc·Product code DZA·July 10, 2017
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications.
FDA Recall
Terminated
·Agfa N.V. Septestraat 27 Mortsel Belgium·Product code JAA·June 27, 2019
AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAA·January 5, 2018
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)
FDA Recall
Terminated
·Philips North America Llc·Product code JAA·September 24, 2021
Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Motor Drive
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAA·August 8, 2003
OEC Uroview 2800 with Dual Monitor Option, fluoroscopic x-ray system, Model Numbers: 882082-01, 882082-02, 886765-01, GE Healthcare, Surgery, Salt Lake City, UT.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·January 15, 2007
MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Systems, Bothell, WA, 98021
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·November 29, 2007
MultiDiagnost Eleva
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·December 10, 2008