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
Accutron is recalling the flowmeter (analgesia gas machine) because when it flows nitrous gas without oxygen gas being turned on, it functions in an incorrect manner.
조치
Accutron sent an Urgent Advisory Notice letter dated April 6, 2012 to all their customers who purchased the Ultra PC% Cabinet Mount Flowmeter. The letter informed the customers of the problem identified and actions to be taken. Customers were instructed to discontinue use or to continue use of the device only with extreme care until a replacement can be installed. Extreme care includes the use of the titration method for nitrous oxide administration coupled with close monitoring of both the patient and the actual gas flow through the flowtubes. For question contact Accutron at (800) 531-2221 or by email at jheadrick@accutron-inc.com.
Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. || Flowmeter, CM Assembly, Model#31970, Serial#13692. || Product Usage: || Conscious Sedation Unit Analgesia Gas Machine.