247 results
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15ms
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Sources: EU EUDAMED, US FDA
Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
FDA Recall
Terminated
·Elekta, Inc.·Product code IXI·January 18, 2013
AD 7 Patient table supplied with Allura Xper FD10 and Allura Xper FD10/10. Product is non-tilting but can be purchased with a tilt option.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IXI·March 14, 2008
DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
FDA Recall
Terminated
·Elekta, Inc.·Product code IXI·August 15, 2013
VS200 radiographic Cassette Holder or Wall Stand. For use in radiology department.
FDA Recall
Terminated
·Del Medical, Inc.·Product code IXY·December 3, 2015
Axxent Flexishield Mini To shape the beam from a low energy radiation therapy source up to 50kVp.
FDA Recall
Terminated
·Xoft Inc.·Product code IXI·February 3, 2011
Siemens mMLC (ModuLeaf) safety bar and trolley label. Siemens Medical Solutions USA, Inc. Concord, CA. The intended use of the Siemens branded mMLC is an accessory used with the Linear Accelerator systems to deliver x-ray photon and electron radiation for the therapeutic treatment of cancer. This accessory shapes the radiation beam, per the leaf parameters, to minimize the amount of dose to outlying tissue.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IXI·February 7, 2012
DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
FDA Recall
Terminated
·Elekta, Inc.·Product code IXI·May 1, 2013
Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical Column, Swivel Arm with variable height, X-ray Tube, Automatic Exposure Control, Collimator, Touch Screen Control and Image Receptor Assembly. The Positioner and the Patient Mobile Table are associated equipment to the Generator X-ray Unit.
FDA Recall
Terminated
·Konica Minolta Healthcare, Americas, Inc.·Product code IXY·November 8, 2018
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table. It is intended to be used in general radiographic applications as a component of a radiographic system.
FDA Recall
Terminated
·Claymount Assembli Anholtseweg 44 Dinxperlo Netherlands·Product code IXY·March 15, 2014
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table.
FDA Recall
Terminated
·Claymount Assembli Anholtseweg 44 Dinxperlo Netherlands·Product code IXY·March 15, 2014
VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department.
FDA Recall
Terminated
·Del Medical, Inc.·Product code IXY·December 3, 2015
The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 0682001286 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/FP), 0682001298 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P), 0682001299 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/5P), 0682001300 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/5P/5P), 0682001433 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P), 0682001434 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/5P), 0682001435 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/9P/5P) Product Usage: The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light
FDA Recall
Terminated
·Stryker Communications·Product code FSY·February 28, 2017
Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems, Model #: AXIS- 882130, IRIX- 882140. Philips Healthcare. Used to do nuclear medicine diagnostic imaging of various body organs.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·November 18, 2011
Portex Dual-Axis Swivel Adapter Catalog Number: 525151
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·September 9, 2004
Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)
FDA Recall
Terminated
·Product code NHX·November 11, 2005
Fiberoptic Bronchoscope Dual-Axis Swivel Adapter Catalog Number: 625191
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·September 9, 2004
Portex PEEP-KEEP Dual-Axis Swivel Adapter Catalog Number: 525351
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·September 9, 2004
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.
FDA Recall
Terminated
·Product code LPS·March 20, 2015
Axis Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·November 21, 2007
Philips Odyssey FX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code LLZ·September 15, 2003