708 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ArrowClarke" PleuraSeal¿ Thoracentesis Kit
FDA Enforcement
Class II
·Terminated·Arrow International Inc·April 11, 2018
X-ray, Computed Tomography, Model TSX101A
FDA Recall
Terminated
·Toshiba American Med Sys Inc·Product code JAK·January 14, 2003
Infinia with Hawkeye 1, model numbers: H2508PW, H2508PY, H3000WN, H3000WR, H3000WW, H3000WY, H3000WZ, H3000YM, and H3000YS. GE Healthcare, Waukesha, Wisconsin 53118. Generating head and whole body CT images of human subjects
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code JAK·August 1, 2009
Brilliance 64 Computed Tomography System, Model #78231, Serial Number: 9592. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 2, 2011
Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 6, 2011
Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 18, 2012
Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·February 15, 2013
Xoran Mini CT Scanner
FDA Recall
Terminated
·Xoran Technologies, Inc.·Product code JAK·July 27, 2010
Xoran Minicat00158
FDA Recall
Terminated
·Xoran Technologies, Inc.·Product code JAK·July 27, 2010
Philips MX8000 IDT CT Scanner, utilizing V2.1 software.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·April 2, 2003
HiSpeed FX/I (2200997-2 with Gantry mo. #2201000-2)
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·February 1, 2010
HiSpeed DX/I (2201000)
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·February 1, 2010
HiSpeed DX/I (2249696)
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·February 1, 2010
LightSpeed 16 Computed Tomography X-ray Systems; LightSpeed 16 Computed Tomography X-ray Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·October 27, 2010
Precedence Imaging System; 6 Slice 3/8; 6 slice 5/8 Philips Medical Systems An imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system.
FDA Recall
Terminated
·Philips Medical Systems·Product code JAK·December 28, 2010
The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 11, 2014
GE LightSpeed VCT Scanner System, models 5212920-300, 5212920-310, 5311595-10. Composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 USA. Is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·September 3, 2010
Gemini GXL PET/CT Systems, 6, 10, 16 slice configurations. (Product Numbers/manufacturer numbers: 16 slice: 4535 679 71891, 10 slice: 4535 679 75691, 6 slice: 4535 679 75691. Catalog numbers: 16 slice: 882410, 10 slice: 882400, 6 slice: 882390.)
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 18, 2005
SOMATOM Emotion 16. Computed tomography X-ray system
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAK·August 5, 2008
SOMATOM Emotion 6. Computed tomography X-ray system
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAK·August 5, 2008