Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
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As reported to radiometer there is a potential risk of receiving an electrical shock under certain conditions. tcm4 series base unit does not comply eith iec 60601-1 2nd edition subclause 15(b).
Model Catalog: POWER SUPPLY 910-246 (Lot serial: 910-246); Model Catalog: 391-876 (Lot serial: 000-154); Model Catalog: 391-880 (Lot serial: 910-246); Model Catalog: 391-878 (Lot serial: 910-246); Model Catalog: 391-876 (Lot serial: 910-246); Model Catalog: POWER SUPPLY 910-246 (Lot serial: serial # below R0175N009); Model Catalog: 000-154 (Lot serial: serial # below R0175N009); Model Catalog: 391-880 (Lot serial: serial # below R0175N009); Model Catalog: 391-878 (Lot serial: serial # below R0175N009); Model Catalog: 391-876 (Lot serial: serial # below R0175N009); Model Catalog: POWER SUPPLY 910-246 (Lot serial: 391-880); Model Catalog: 000-154 (Lot serial: 391-880); Model Catalog: 391-880 (Lot serial: 391-880); Model Catalog: 391-878 (Lot serial: 391-880); Model Catalog: 391-876 (Lot serial: 391-880); Model Catalog: POWER SUPPLY 910-246 (Lot serial: 391-878); Model Catalog: 000-154 (Lot serial: 391-878); Model Catalog: 391-880 (Lot serial: 391-878); Model Catalog: 391-878 (Lot serial: 391-878); Model Catalo