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
Anesthetic agents could be delivered at concentrations above the concentration set on the s/5 and as/3 anesthesia delivery units (adu) having serial numbers within a specified range.
조치
Recall letters dated February 03, 2004 stated that a firm representative would contact the consignee to schedule a visit to replace software and hardware to correct the problem.
The product was distributed nationwide to hospitals in the Unites States.
제품 설명
Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units || (The S/5 units are a later version of the AS/3 units. The conversion from AS3 to S5 occurred during the summer of 2000. This change was mainly a product name change, with a slight color variation to the shade of white being used externally on the machine. There were no design or feature and function modifications when the name change occurred.)