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
Interface Cables - Product Code MWI
원인
Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. in certain orientations, the transducer causes the invasive blood pressure readings on the physiological monitor to display inaccurate readings.
조치
The recalling firm contacted all affected customers via telephone or letter dated November 20, 2006 to inform them of the problem and instruct them to return the cables or apply corrective labeling.
Worldwide distribution ---- including USA state of CA, CO, HI, IL, IN, MA, MD, NJ, NY, OH, PA, TX, and WA and countries of The Netherlands, Denmark, Australia, Brazil, Italy, and Japan.
제품 설명
Invasive Blood Pressure Interface Cables: a) || Medrad 9500 Multigas monitor for MRI, Invasive Blood Pressure Interface Cable (Part # 3006314) for use with Abbott/Hospira IBP Transducer b) Invasive Blood Pressure Interface Cable (Part # 3008772) for use with Braun IBP Transducers. The product is an accessory to patient physiological monitor.