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
Catheter, continuous flush - Product Code KRA
원인
The connector interface cable (cic) was not recognized by the ekosonic pt-3b control unit.
조치
Ekos sent an "Urgent Voluntary Medical Device and Replacement" letter dated June 24, 2015, to US customers. The letter identified the product the problem and the action needed to be taken by the customer.
The replacement CIC and recall letter were sent by FEDERAL EXPRESS directly to the person responsible for maintaining the EkoSonic System. Tracking numbers and delivery notifications will be retained for each shipment.
Letters to Risk Management and Purchasing were sent by REGISTER MAIL. The return cards will be retained for each letter.
Customers with questions can contact EKOS Customer Service at 1-888-400-3567.
The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. || The EkoSonic Endovascular System consists of three main components: || -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and || -removable MicroSonic Device (MSD), and || -a reusable EKOS EkoSonic Control System. || During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. || The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. || A reusable, nonsterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.