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
Removal from the market of certain references and batches of the "Securmix" devices, due to the possibility that fragments of the blue key are detached and are suctioned by the syringe used with 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
Identification of certain problems related to the GemStar Infusion Pump Family
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
The expected retention force in the blue color codes of the ORTHOCORD ™ Sutures is 80% of its original strength six weeks after implantation, and not 100% as it appears in the instruction for use.
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
Withdrawal from the market of certain batches of the Impactor / Extractor of the Tibial Triathlon Base Plate, ref. 6541-4-805 due to the possibility of the handle separating from the cam.
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 random flow readings and / or intermittent false flow alarms in certain Advanced System 1 Perfusion Systems from Terumo®, when there is no tube in the flow sensor.
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 deviations in the values of results of rheumatoid factor of the patients, with the batch 244560 of the liquid calibrator specific of proteins (LSP) for the systems ADVIA ® of chemistry
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
Defect in the master side connector block of the pneumatic tool changer could introduce inclination in compartments of the collimator of certain CyberKnife systems, which could cause displacement towards the central axis of the radiation beam.
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
Recall from the market of certain references and batches of Kimguard Filters for containers because they could have thinner areas that could compromise the ability of the filter to act as a sterile barrier
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
Removal from the market of certain batch numbers of the 2.0 mm Kirschner wire clamp because the ball and nut assembly would not engage the threads of the distractor arm and, as a result, could lock in place.
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 failure in the unique identification of series (UID) of the products Optima CT660, Brivo CT385, Discovery PET / CT 610 and Discovery PET / CT 710 and appear in the same examination images of two or more patients.
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
Withdrawal from the market of lot 11041 of product B • H • A • H • M • S CYFRA 21-1 KRYPTOR, reference 811050, manufactured by Brahms GmbH, Germany, due to the possibility of incorrect values being generated due to insufficient reconstitution.
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
Cessation of the use of lot 59107A of the control reagent "BRAHMS PLGF plus KRYPTOR QC", reference 85992, manufactured by BRAHMS GmbH, part of Termofisher Scientific, Germany, because the expiration date printed on the label of the reagent is incorrect.
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 positions of isocenters and RT structures are incorrect when using the DICOM "Full Export" function with version 4.1 of iPlan RT Dose, manufactured by Brain AG, Germany.
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 dose is incorrectly calculated after modifying the fields delimited by the MLC with version 4.0 and 4.1 of the iPlan RT Dose treatment planning software, manufactured by Brain AG, Germany.
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
Removal from the market of all batches of certain references of the urine collection bag with belt Belly Bag® of Rusch®, due to a defect in the package that may compromise the sterility of the product.
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
Reduction of the expiration date and as a consequence cessation of the use of certain batches of the "Calibrators and Controls ARCHITECT STAT High Sensitive troponin- I", Reference 3P25-01
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
Removal from the market of certain radiolucent defibrillation electrodes for adults and pediatric Medi-Trace ™ Cadence, due to the possible appearance of electric arcs and sparks that could prevent the administration of the discharge to 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
Withdrawal from the market of certain batches of the BodyGuard MICROSET Infusion System, manufactured by Caesarea Medical Electronics (CME) Limited, Israel, due to the possibility that the sterility of the product is compromised.
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 security problem with the "Light Delivery Device (LDD)" system, manufactured by Calhoun Vision Inc., USA, which could be related to the intensity of the white annular lights.