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
Injector and syringe, angiographic - Product Code DXT
원인
Software version sw 005.006_sh, resulted in the removal of purge enforcement from traditional new-case, power up and syringe change use cases while the injector head is in the upright position.
조치
Direct accounts were notified by UPS Notification letter dated August 4, 2015 and advised when using the Arterion Injection System to ensure that purges are completed to avoid the injection of air.
Worldwide Distribution. US Nationwide, Germany, France, UK, Netherlands, Sweden, and Canada.
제품 설명
Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.