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
Philips healthcare has discovered through trend analysis an increase in the failure rate of certain low-voltage dc power supplies ("dcps") used in these products. each system contains multiple dcps some of which may be subject to an increased probability of failure. failure of a dcps may result in the sudden loss of imaging functionality or mechanical movement depending on what subsystems the dcps is powering.
Model Catalog: 722026 (Lot serial: 271); Model Catalog: 722026 (Lot serial: 534); Model Catalog: 722028 (Lot serial: 663); Model Catalog: 722028 (Lot serial: 758); Model Catalog: 722028 (Lot serial: 763); Model Catalog: 722038 (Lot serial: 97); Model Catalog: 722038 (Lot serial: 110); Model Catalog: 722038 (Lot serial: 102); Model Catalog: 722028 (Lot serial: 742)
제품 설명
ALLURA XPER FD10 (PRODUCT OF ALLURACLARITY FAMILY);ALLURA XPER FD20 (PRODUCT OF ALLURACLARITY FAMILY);ALLURA XPER FD20/20 (PRODUCT OF ALLURACLARITY FAMILY)