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.
Notas adicionales en la data
Acción
Possibility of an unforeseen movement during the movement of the mobile digital radiography units DX-D 100
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.
Notas adicionales en la data
Acción
Removal of the manual switch from the CT Exprès ™ 3D Contrast Injection System due to the possibility of administering more contrast than indicated.
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.
Notas adicionales en la data
Acción
Possible loss of the parameters of the Patient Data Module (PDM) when connected to certain CARESCAPETM B850, B650 or B450 Monitors
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.
Notas adicionales en la data
Acción
Possibility that the touch screen of the Digital X-ray System DX-D 100, is activated unintentionally when coming into contact with a liquid.
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.
Notas adicionales en la data
Acción
Updating of the Instructions for Use of the Dilatation Catheter for ACTP RX NC Cordis EMPIRA ™ (75RxxyyyN) and of the Dilatation Catheter for ACTP RX Cordis EMPIRA ™ (85RxxyyyS)
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.
Notas adicionales en la data
Acción
Possibility of showing erroneous values when using Version 01 of the Neuromuscular Transmission Module (E-NMT-01), together with the ElectroSensor and connected to the anesthesia monitors CarescapeTM or Datex-Ohmeda S / 5.
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.
Notas adicionales en la data
Acción
Withdrawal from the market of certain serial numbers of the products "Astrada intrathecal catheters" (models 8780 and 8781) and "Ascenda revision kit" (model 8784), due to the possibility of failure of the catheter retention ring
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.
Notas adicionales en la data
Acción
Possibility of incorrect patient selection in the Wireless Digital Radiography System (WDR1) of the Precision 500D and Proteus XR / a devices
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.
Notas adicionales en la data
Acción
Possible loss of sound in certain CARESCAPETM B650 Monitors, when connected to an external screen.
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.
Notas adicionales en la data
Acción
Additional information related to the possible mechanical failure in the fan of certain intra-aortic counterpulsation consoles (IABP) Datascope System 98 / 98XT, CS100® / CS100i and CS300 ™.
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.
Notas adicionales en la data
Acción
Possibility of cracks in the condenser of certain oxygen concentrators Invacare® Platinum® and PerfectO2®, manufactured by Invacare Rehabilitation Equipment (Suzhou) Co., Ldt, China, which could cause fire risk.
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.
Notas adicionales en la data
Acción
Replacement of components in certain brackets for monitors and articulated arms with VESA 75/100 rotating adapter, manufactured by ITD GmbH, Germany, by not complying with the specifications which could lead to the detachment of the connection plate.
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.
Notas adicionales en la data
Acción
Removal of the lot 7120306010 from the TheraSorb TPE LIFE 18 Tubing Set, due to the possibility of leakage under the drip chamber of one of the system's replacement lines.
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.
Notas adicionales en la data
Acción
Replacement of components in certain supports for monitors and articulated arms with VESA 75/100 rotating adapter, manufactured by ITD GmbH, Germany, included in the endoscopy carts distributed by Stryker Corporation, as they do not comply with the specifications.
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.
Notas adicionales en la data
Acción
Possibility that the hinge of the reagent cover of the Dimension® EXL ™ 200, LM and STM integrated systems may lose its effectiveness and the lid may go down slowly during maintenance procedures.
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.
Notas adicionales en la data
Acción
Possible adverse tissue reaction in patients sensitive to Cobalt (Co) and Nickel (Ni), when using the Guide Needle of 3.2 mm in diameter and 400 mm in length, due to the incorrect identification of the raw material in the labeling.
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.
Notas adicionales en la data
Acción
Removal from the market of certain references and batches of heat exchangers for cardioplegia PLEGIOX, due to the possible discrepancy between the cardioplegia temperature measured through the external temperature probe and the temperature
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.
Notas adicionales en la data
Acción
Possibility that during the recording of a D-ECG for diagnosis in the Corpuls3 equipment with software version 2.2.2, an unintentional distortion of the R peak or the ST segment may occur.
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.
Notas adicionales en la data
Acción
Ejection fraction calculation errors in the a2DQ and aCMQ patient studies, when applying certain versions of the QLAB Advanced Quantization Software, when it is integrated into a Philips PACS or a PACS from another company.
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.
Notas adicionales en la data
Acción
Detection in the European market of the product "Aqua secret HA", syringes containing gel of hyaluronic acid for facial filling, in which it appears as a manufacturer, Jointlaser Technology, Ltd, China, with a false CE mark.
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.
Notas adicionales en la data
Acción
Cessation of the use of lot 1320 of the VITROS® CA 19-9 reagent package, and review of the results, due to the possibility of obtaining positively biased results
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.
Notas adicionales en la data
Acción
Update to version BBR / 02 of the 8870 model software card used with the programmer of the model 8840 doctor, to correct the possibility of loss of the programmed stimulation in certain neurostimulators.
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.
Notas adicionales en la data
Acción
Certain batches of tattoo inks and needles marketed by "White & Blue Lion, Inc." in the United States may be microbiologically contaminated.
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.
Notas adicionales en la data
Acción
Detection of a false CE marking certificate for "Dream eye" contact lens care solutions manufactured by K & JC CO., LTD, Republic of Korea.
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.
Notas adicionales en la data
Acción
Removal from the market of certain references and batches of ProcedurePack® trays, because certain sterile tubes included in the trays may not have received the proper sterilization dose