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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Review of test records indicated that the seven impacted powerhart g3 aeds manufactured by cardiac science corporation (csc) may not have received adequate testing prior to being shipped from the factory.
Model Catalog: 9300E-501 (Lot serial: Serial # 4153683); Model Catalog: 9300E-501 (Lot serial: Serial # 4153329); Model Catalog: 9300E-501 (Lot serial: Serial # 4218441); Model Catalog: 9300A-501PPC (Lot serial: Serial # 4230260ppc); Model Catalog: 9300P-601 (Lot serial: Serial # 4226121); Model Catalog: 9390E-501 (Lot serial: Serial # 4237595); Model Catalog: 9390A-501 (Lot serial: Serial # 4183220)