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
The manufacturer identified certain medrad mark 7 arterion injection systems which utilize software version sw 005.006_sh have a potential situation involving the purge enforcement procedure. in the absence of purge enforcement in arterion software version sw 005.006_sh users / technologists may not purge the fluid path.
Model Catalog: ART 700 OCS (Lot serial: 20422); Model Catalog: ART 700 PEDL (Lot serial: 100785); Model Catalog: ART 700 TABL (Lot serial: 20735); Model Catalog: ART 700 TABL (Lot serial: 101149)
제품 설명
MEDRAD MARK 7 ARTERION INJECTION SYSTEM (CEILING MOUNT SYSTEM)