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.
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Withdrawal from the market and replacement of all ureterroneal videoendoscopes URF-V2 and URF-V2R and all ureterroneal fiberscopes URF-P6 and URF-P6R due to possible rupture of the curved section of the endoscope insertion tube during surgical 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.
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Action
Security warnings due to the possibility of a database management error during the image acquisition process, causing one or more "series of images" to be missing in a scan, without the display appearing in the viewer No warning to report it.
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.
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Action
Safety warning related to the loading instructions of the shaver to avoid potential degradation of the lithium-ion battery that could cause excessive heating during operation or a failure in the load.
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.
Extra notes in the data
Action
Removal from the market of certain references and batches of the intrauterine devices (IUDs) ANCORA, NOVAPLUS® and GOLD T®, due to the possible breakage of the horizontal arms at the moment of extraction.
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.
Extra notes in the data
Action
Removal from the market of certain references and batches of infusion equipment used with Medtronic's Minimed insulin pumps, due to possible equipment malfunction that could cause insulin overinfusion.
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.
Extra notes in the data
Action
Safety warning related to a possible failure of automatic and manual ventilation in Fabius anesthesia systems, due to an excess amount of oil during the production stage that could interfere with the detection of the position of the ventilation motor.
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.
Extra notes in the data
Action
Safety warning related to the possibility that Berchondold Chromophare DFP monitor stands have insufficient welding.
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.
Extra notes in the data
Action
Safety warning regarding the possibility that automatic measurements of QC (AutoQC - quality control) previously programs in certain systems cobas b 221, due to a software problem are no longer performed.
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.
Extra notes in the data
Action
Safety warning and update of the instructions because the PMH 7000 Humidifier Bases are not equipped with a water deficiency detection alarm so it is necessary to regularly check the water levels in the humidification chamber.
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.
Extra notes in the data
Action
Cessation of the use and withdrawal from the market of certain references and batches of the collagen-based meniscal implant, because they were shipped without the required temperature control package, so they could have been exposed to elevated temperatures during transport, whose case the implant might not provide sufficient reinforcement of the soft tissue.
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.
Extra notes in the data
Action
Cessation of use and withdrawal from the market of certain references and batches of the tibial components of the Triathlon Total Knee System because the packaging labeling may not correspond to the size of the product included.
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.
Extra notes in the data
Action
Safety warnings due to the possibility of biotin interferences in the INMULITE®2000 / INMULITE® 2000 XPi IgG4 allergen-specific IgG4 assay, which could bias the 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.
Extra notes in the data
Action
Safety warnings due to the incorrect indication in the instructions for use about the maximum magnetic field a patient carrying these implants can receive when subjected to an MRI scan.
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.
Extra notes in the data
Action
Safety warnings because when using MATCH IT! DNA v1.2.3 and V1.2.24 (with the Pairwise OFF functionality) on a Win 7 32-bit computer for HLA-A typing analysis, an error can occur with the A2 typing homozygous or with an A2 on the pair of alleles . The results generated in these conditions must be reviewed.
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.
Extra notes in the data
Action
Withdrawal from the market of lot MP17288 (printed on the box) and 703061 (printed on the bottle) of the contact lens solution MeniCare Soft 70ML, because the sterility of the product can not be guaranteed.
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.
Extra notes in the data
Action
Cessation of the use of the EliA TSH-R wells of lot 0014, having detected an incorrect operation that can produce a decrease in the response units, obtaining higher concentration values in the samples analyzed, and reviewing the results obtained with this lot.
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.
Extra notes in the data
Action
Safety warning related to cleaning the distal tip of the endoscopes to avoid coagulation or fixation of possible substances adhered to the lens when connected to the VP-7000 / BL-7000 system and updating the system software to version 1.011 for reduce the volume of light in the distal tip of the endoscope.
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.
Extra notes in the data
Action
Safety warnings due to the possibility that a customized database has been installed whose use could cause the communication of unsupported results for various combinations of antimicrobial / microorganism giving rise to incorrect values of sensitivity or minimum inhibitory concentration (MIC) for the that MicroScan panels are not suitable.
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.
Extra notes in the data
Action
Cessation of marketing and maintenance and withdrawal from the market of certain references of Vylife devices, due to the detection of a problem that would require the replacement of the battery and the complete validation of the product at the regulatory level.
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.
Extra notes in the data
Action
Safety warning related to an error in table 1: panel BD OneFlow B-CLPD T1, on page 7 of the instructions for use, regarding the description of the clone for the CD10 PE conjugate.
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.
Extra notes in the data
Action
Cessation of the use of batch 1765821 of the Oxoid ™ Mueller-Hinton Broth culture medium code CM0405B, because the product label provides incorrect information of the Magnesium cation, which could cause errors in the quality control, reports of incorrect results or delays in the 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.
Extra notes in the data
Action
Safety warning related to the possibility that a component of the braking system does not work properly and causes one or more of the brake pedals not to engage or snap into the "brake" position, so that a movement could occur desired from the bed and, as a consequence, the patient or the user could suffer some injury.
Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), 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 Singapore.
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.
Extra notes in the data
Action
Safety warnings because the joint use of the old control units of the heating systems with blankets and heating mattresses manufactured since February 2013, can measure and display on the screen of the control unit the most value Low temperature generated by heating the blanket / mattress, which can lead to potentially dangerous temperatures.
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.
Extra notes in the data
Action
Safety warnings and update of the instructions for use, due to the increase in notifications of ruptures of the Capio sutures and / or detachment of the darts of the Capio suture and of the pelvic floor kit mesh assembly, when subjected to a excessive tension during placement.