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
Certegraworkstation when used in conjunction with the medrad stellant ct injection system may exhibit thermal events, such as: smoke and sparks of fire.
조치
Bayer Healthcare mailed an Urgent Field Safety Notification letter on August 03, 2016 to customers who were affected by the recall informing them of the issue and what actions to take if they were impacted. Customers were advised to use the enclosed Interim Instructions for Use for further information. For questions customers should call 1-877-229-3767.
Worldwide Distribution - US (nationwide) and Internationally to United Arab Emirates, Australia, Canada, Germany, Spain, and United Kingdom.
제품 설명
Certegra Workstation used in conjunction with Medrad Stellant CT Injection System || Catalog Number # CWKS DISPLAY || Serial Numbers || The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications