72 results
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12ms
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Sources: EU EUDAMED, US FDA
Extended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System Model Numbers EBW (CT) 728260 & EBW (Portal) 728269. The Extended Brilliance Workplace (EBW) is a component of the Computed Tomography X-Ray System that is 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. The EBW is also provided as a component of PET/CT and SPECT/CT systems, performing the same function as indicated above (also referred to as the NM EBW).
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·October 3, 2009
Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code LPH·February 28, 2017
Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is 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 KPS·September 28, 2012
Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is 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 28, 2012
3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.
FDA Recall
Terminated
·OrthoPediatrics Corp·Product code HWC·July 27, 2016
3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.
FDA Recall
Terminated
·OrthoPediatrics Corp·Product code HWC·July 27, 2016
Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging.
FDA Recall
Terminated
·Mallinckrodt Inc·Product code DXT·April 14, 2008
Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
FDA Recall
Terminated
·Allen Medical Systems·Product code JEB·October 6, 2017
Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code LPH·February 28, 2017
The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography equipment. The J-Bow component is used to connect the powerhead to a suspension system.
FDA Recall
Terminated
·Mallinckrodt Inc·Product code IZQ·April 7, 2008
Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 24, 2012
Segmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous uncemented prosthesis- Specific Knee, Hip and Nail Implants
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code LZO·February 28, 2017
Philips BV300 Mobile X-Ray System
FDA Recall
Terminated
·Philips Medical Systems·Product code IZL·September 27, 2002
ALFA II Modular Femoral Left Modular Stem Porous Coated (Bowed); Size 6 Left; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180L; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 78758.
FDA Recall
Terminated
·Product code JDI·April 12, 2007
ALFA II Modular Femoral Right Modular Stem Porous Coated (Bowed); Size 6 Right; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180R; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 78758.
FDA Recall
Terminated
·Product code JDI·April 12, 2007
Philips Medical Systems -- Cardiac Viewer or Pulmonary Viewer software application version 2.0 in use with Precedence SPECT/CT System and all CT EBW workstations using software version 3.5. Philips Nuclear Medicine, Milpitas, CA 95035
FDA Recall
Terminated
·Phillips Nuclear Medicine·Product code KPS·September 28, 2007
OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY. Hip and knee joint replacement prostheses intended for primary and revision joint arthroplasty for use in cemented applications.
FDA Recall
Terminated
·Biomet, Inc.·Product code KRO·November 1, 2011
Restoration Modular Conical Distal Bowed Stem. 14 mm x 195 mm; Stryker Orthopaedics. Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LZO·June 26, 2009
Restoration Modular Conical Distal Bowed Stem. 14 mm x 235 mm; Stryker Orthopaedics. Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LZO·June 26, 2009
SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAK·June 4, 2015