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
Ventilator, continuous, facility use - Product Code CBK
원인
Servo-i and servo--s ventilator systems are equipped with a specific revision of a printed circuit board (pc1772 revision 22) that includes a component that has generated a number of nuisance alarms due to technical error message 24 (te 24).
조치
The firm, Maquet Getinge Group, sent an " PRODUCT RECALL URGENT - MEDICAL DEVICE CORRECTIVE ACTION" letter dated September 19, 2011, to its customers. The letter describes the product, problem and actions to be taken. Maquet service team will contact the customers within two weeks of receiving this letter to schedule an on-site service of the affected equipment.
If you have any questions, call technical support at our toll free number at 1-888-627-8383.
Maquet Servo-i ventilator system || Device Part number 64 87 800 || Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport.