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
Electrosurgical Electrode Kit - Product Code NWI
원인
Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ecg.
조치
Letter was sent on 9/24/2004 via FedEx to the three customers with proof of delivery required.
Shipments made to three locations. These are Medstone Internation, Aliso Viejo, CA; Indiana Eye Clinic, Greenwood, IN; and Sumter Urologoly Assoc., Sumter, SC.
제품 설명
Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).