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 was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
PAC System/Report Management - Product Code LLZ
원인
Reporting differences: the outbound report software produces an outbound report (text version) which does not contain all the clinical content elements present in the pdf version of the report, also generated on the nuclear cardiology reporting module.
조치
All five (5) sites utilizing this product were notified about the issue directly via telephone. An "Urgent Safety Notice" was sent via FED-EX to all the sites using the product on February 22, 2008. The letter describes the potential issue and mitigation. The recalling firm will also visit each site and make configuration changes to resolve this issue.