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 has discovered through trend analysis an increase in the failure rate of certain anode drive units (adus) used in these products. early life failure of the adus only occurs when the hospital mains provide 480v to the system. when the adu fails the x-ray performance of the system is reduced to emergency fluoroscopy. exposure will not be possible and image quality is reduced.
Model Catalog: 722058 (Lot serial: 110 / 65331325); Model Catalog: 722035 (Lot serial: 111 / 67475814); Model Catalog: 722035 (Lot serial: 128 / 68199187); Model Catalog: 722038 (Lot serial: 102 / 65331332); Model Catalog: 722028 (Lot serial: 1261 / 70828850); Model Catalog: 722028 (Lot serial: 1056 / 69430666); Model Catalog: 722028 (Lot serial: 1039 / 69397862); Model Catalog: 722028 (Lot serial: 942 / 68733944); Model Catalog: 722028 (Lot serial: 663 / 66650325); Model Catalog: 722028 (Lot serial: 878 / 68280389); Model Catalog: 722028 (Lot serial: 763 / 67493645); Model Catalog: 722028 (Lot serial: 758 / 67476532); Model Catalog: 722028 (Lot serial: 742 / 67341881); Model Catalog: 722028 (Lot serial: 905 / 68002624); Model Catalog: 722026 (Lot serial: 759 / 69723007); Model Catalog: 722026 (Lot serial: 866 / 67402179); Model Catalog: 722026 (Lot serial: 830 / 70417112); Model Catalog: 722026 (Lot serial: 271 / 64615994); Model Catalog: 722026 (Lot serial: 707 / 69150243); Model Catalog: 722026 (Lot seria
제품 설명
ALLURA XPER FD20/15;ALLURA XPER FD20 OR TABLE (PRODUCT OF ALLURACLARITY FAMILY);ALLURA XPER FD20/20 (PRODUCT OF ALLURACLARITY FAMILY);ALLURA XPER FD20 (PRODUCT OF ALLURACLARITY FAMILY);ALLURA XPER FD10 (PRODUCT OF ALLURACLARITY FAMILY)