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
Pentax medical has become aware that some customers may not have been provided with an isolation transformer when they purchased a pentax medical computer system mounted to a cart. the electrical safety requirements for these systems requires the use of an isolation transformer to protect patients from electrical shock.
Model Catalog: MODEL 9200C (Lot serial: 41861-16/CDC15A47600); Model Catalog: MODEL 9310HD (Lot serial: 4015609/B4LMQS001473); Model Catalog: MODEL 9200C (Lot serial: 33413-10/81J01621NA)
제품 설명
Digital Video Capture Module;HD-DIGITAL VIDEO CAPTURE