Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Extra notes in the data
FAN 915-302
Action
Modification of the software. Modification of the manual.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Extra notes in the data
FAN 915-302
Action
Reminder of important information. Modification of instructions.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Extra notes in the data
FAN 915-374
Action
Information on the risk of use. Modification of the software.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Extra notes in the data
FAN 915-320
Action
Information on the risk of use. Modification of the software.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Extra notes in the data
FAN 915-335
Action
Information on the risk of use. Modification of the software.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Extra notes in the data
FAN 915-290
Action
Instructions on use of the products. Software upgrade.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Extra notes in the data
FAN 915-353
Action
Information on the risk of use. Temporary measures. Modification of the software. Modification of the manual.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Extra notes in the data
March 31, 2017
Action
Information on the risk of use. Temporary measures.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Extra notes in the data
EU-022013-002 (FSCA 20485)
Action
Information on the risk of use. Modification of products. Follow-up patient.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Extra notes in the data
FA-30576
Action
Information on the risk of use. Modification of the manual
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Extra notes in the data
EU-072012-015
Action
Products should be discarded. Control of the test results.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Extra notes in the data
FA-28096
Action
Information on the risk of use. Products should be taken out of service. Temporary measures.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Extra notes in the data
EU-112012-018 (FSCA-19767-2)
Action
Products should be taken out of service. Control of the test results.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Extra notes in the data
EU-032013-004, FSCA 19073-2
Action
Information on the risk of use. Products should be taken out of service.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Extra notes in the data
EU-112011-036
Action
Products should be taken out of service. Products should be discarded. Control of the test results.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Extra notes in the data
EU-032012-009
Action
Products should be discarded. Control of the test results. Overtaking sample. New sampling.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Extra notes in the data
EU-042011-019
Action
Instructions on use of the products. New instructions. Control of the test results.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
Extra notes in the data
EU-072315-003 (FSCA-25775)
Action
Products should be taken out of service. Modification of the software. Follow-up patient.