18 results
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34ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".
FDA Enforcement
Class II
·Terminated·Philips And Neusoft Medical Systems Co., Ltd.·August 1, 2012
NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".
FDA Recall
Terminated
·Philips And Neusoft Medical Systems Co., Ltd.·Product code JAK·February 9, 2011
NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".
FDA Recall
Terminated
·Philips And Neusoft Medical Systems Co., Ltd.·Product code JAK·June 8, 2012
The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as NeuViz Dual, PN: 989605651321. Labeling on the device reads in part: "***Neusoft NeuViz Dual MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD. ADDRESS: NEUSOFT PARK, HUN NAN INDUSTRIAL AREA, SHENYANG 110179, CHINA***". Device is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles.
FDA Recall
Terminated
·Philips And Neusoft Medical Systems Co., Ltd. Neusoft Park, Hun Nan Industrial Area Shenyang, Liaoning China·Product code JAK·February 10, 2010
Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, 2282860, 2282880, 2352129, 2388781, 5105123, 5113339, 2138300-32, 2189500-3, 2198999-4, 2259620-4, 2262700-2, 2269512-2, 2286849-2, 2352129-2, 2377062-5, 2377062-8, Manufactured by GE Hangwei Medical Systems Co., LTD, Beijing PR, China
FDA Recall
Terminated
·GE Healthcare·Product code LNH·December 31, 2006
NeuViz Dual series Computed Tomography (CT) Scanner System, X-Ray System. Part Number: 989605651321. Intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.
FDA Recall
Terminated
·Neuisys, LLC·Product code JAK·July 21, 2008
GE 9100c NXT anesthesia systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems China Co., Ltd.·September 5, 2018
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems China Co., Ltd.·September 5, 2018
GE Carestation 30 anesthesia systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems China Co., Ltd.·September 5, 2018
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
FDA Recall
Terminated
·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code BSZ·July 24, 2018
GE Carestation 30 anesthesia systems
FDA Recall
Terminated
·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code BSZ·July 24, 2018
GE 9100c NXT anesthesia systems
FDA Recall
Terminated
·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code BSZ·July 24, 2018
NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
FDA Recall
Terminated
·Neusoft Medical Systems Co., Ltd. No. 177-1 Cuangxin Road Hunnan District Shenyang China·Product code JAK·October 22, 2018
NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
FDA Recall
Terminated
·Neusoft Medical Systems Co., Ltd. No. 177-1 Cuangxin Road Hunnan District Shenyang China·Product code JAK·October 22, 2018
NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
FDA Recall
Terminated
·Neusoft Medical Systems Co., Ltd. No. 177-1 Cuangxin Road Hunnan District Shenyang China·Product code JAK·October 22, 2018
NeuViz Dual series computed Tomography Scanner System, X-Ray System The CT scanner is a whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle.
FDA Recall
Terminated
·Philips And Neusoft Medical Systems Co., Ltd. Neusoft Park, Hun Nan Industrial Area Shenyang, Liaoning China·Product code JAK·December 17, 2007
NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
FDA Recall
Terminated
·Philips and Neusoft Medical Systems Co., Ltd. No. 2 Xiu xiu Street Hunnan; Sujiatun Shenyang China·Product code JAK·March 24, 2016
GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.
FDA Recall
Terminated
·GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
No. 2 Yong Chang North Rd.
Beijing Econ. & Tech. Dev. Zone
Beijing China·Product code OXO·September 18, 2013