The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Possible administration of an incorrect clinical treatment with the range of Elekta Precise ™ tables, serial numbers 124001 to 126924, from 133801 to 133999 and from 213000 to 213189, manufactured by Elekta Limited, United Kingdom, due to the accidental rotation of
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Possibility that the "Synergy XVI with certain software versions", manufactured by Elekta Limited, United Kingdom, could incorrectly calculate the objective position of the treatment table and cause a collision between the patient and the patient.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Installation of a modification in the anchoring mechanism of the column of certain Elekta Precise ™ tables, manufactured by Elekta Limited, United Kingdom.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Expansion of the software versions of the "Synergy XVI" equipment, manufactured by Elekta Limited, United Kingdom, which can incorrectly calculate the target position of the treatment table and cause a collision between the patient and the device
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Possibility that the "OF" brand screws used to install the counterweight of the gantry drum in certain digital linear accelerators, manufactured by Elekta Limited, UK, are defective.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Possibility of generating a position error with certain Precise ™ treatment tables, manufactured by Elekta Ltd, United Kingdom, due to incorrect installation of the position sensors.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Possible breakage of the ceramic body of the Semikron diode installed in the SL75 / 5 linear monoergic accelerators, manufactured by Elekta Ltd. United Kingdom, due to incorrect operation of the diode.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Risk that the pins of the traction wheels of the gantry base of certain digital accelerators equipped with XVI, manufactured by Elekta Ltd., United Kingdom, are loosened and broken.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Installation of a Modification Kit in certain linear accelerators with Synergy platform equipped with XVI, manufactured by Elekta Ltd., United Kingdom, due to the risk of loosening of the pins of the traction wheels.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Mandatory modification in the 3DLINE DMLC systems that are part of the Elekta digital accelerators, manufactured by Elekta Ltd., United Kingdom, to continue using them, due to the possibility of clinical errors
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Risk that the pins of the traction wheels of the gantry base of certain digital linear accelerators Precise and Synergy Platform without XVI, manufactured by Elekta Ltd., United Kingdom, are loosened and broken.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Possibility of placing the patient in an incorrect position by pressing the "Edit" button or entering correction of the correction card in system XVI, manufactured by Elekta Ltd. UK, so that incorrect treatment could be administered
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Possibility that the screws that fix the stretcher of the robotic system of patient positioning "System RT HexaPOD ™ evo", manufactured by Medical Intelligence Medizintechnik GMBH, Germany, are released with the passage of time
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Possibility of continuing the workflow in the "HexaPOD evo with iGUIDE RT Systems", manufactured by Medical Intelligence Medizintechnik GmbH, Germany, even though the iGUIDE key is in the off position.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Possible incorrect distribution of the dose when using the "Tumor Overlap Fraction" option during the planning of VMAT (Modulated Intensity Volumetric Arcotherapy), in the radiotherapy planning system "Oncentra® External Beam", manufactured by Nucletron BV, Holland.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Possibility of contouring "horned" figures near the end of the field, by inserting a Varian physical wedge into the "Oncentra® External Beam Oncentra® Brachy" systems, manufactured by Nucletron BV, the Netherlands.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Possibility of an involuntary movement of the gastric balloon fixation safety valve of the implantation system of the SX-ELLA Danis endoprosthesis, manufactured by ELLA-CS, sro, Czech Republic.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Important update, with changes related to safety, in the instructions for use of the device "Nellix endovascular aneurysm closure system", manufactured by Endologix, USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Possibility that with the Nellix endovascular aneurysm closure system, manufactured by Endologix, USA, the water-soluble polymer used to fill the aneurysm solidifies in the filling channel of the administration system and prevents the complete filling of the endo bags.