U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
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 data.
데이터 추가 비고
unknown device name - Product Code ITF
원인
Product contains an improper bracket for the transducer.
조치
Notification of the manufacturing defect and recall was initiated by telephone on 05/30/2003 to the domestic accounts and via email to the foreign accounts.