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
Gas-machine, anesthesia - Product Code BSZ
원인
Specific aespire 7900 anesthesia machines have an increased likelihood of failure of the cpu circuit board. this could result in a blank display or loss of mechanical ventilation.
조치
Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 34064, dated February 27, 2015. The letter was addressed to Chief of Anesthesia, Health Care Administrator / Risk Manager and Director of Biomedical / Clinical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The letter stated that customers can continue to use the affected device in Manual Ventilation mode, and contact their local GE Healthcare Service Representative. GE Healthcare will correct all affected devices at no cost to the customers. A Service Representative will contact customers to arrange for the correction. For questions or concerns contact GE Healthcare Service at 1-800-437-1171, or your local Service Representative.
Worldwide Distribution -- US, including the states of NC and OK; and the countries of CHINA, INDIA, JAPAN, MEXICO, and VENEZUELA.
제품 설명
GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000. || Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients