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.
데이터 추가 비고
원인
Distributed actiwatch spectrum plus devices have exhibited battery related issues leaving the device inoperable and unable to collect data. the battery failures occur out of box or prematurely after 1 to 10 days of use. normal battery life for a fully charged battery is 50 to 60 days.
Model Catalog: 1101894 (Lot serial: Serial number P60004); Model Catalog: 1101894 (Lot serial: Serial number P60015); Model Catalog: 1101894 (Lot serial: Serial number P60016)