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
Calculator, pulmonary function data - Product Code BZC
원인
The purpose of the recall is to replace data transmission cable (usb-cable) connecting the lnnocor device with an external computer.
the replacement usb cable will provide galvanic isolation of the lnnocor from the external computer via opto-couplers, as opposed to the grounding protection currently in use.
the replacement is intended to prevent risk of electric shock.
조치
Recall notifications described the issue and actions to be taken by the firm. The notice also stated that replacement costs would be carried by Innovision ApS. Acknowledgment of the notice can be made by contacting service manager Knud Pedersen at kp@innovision.dk or (+45) 65 95 91 00) to schedule the service activity and to answer any questions.
Worldwide Distribution -- US, to Massachusetts and Washington, DC; and, the countries of Canada, Germany, and United Kingdom.
제품 설명
Innocor Cardiopulmonary Exercise and Lung Function Testing System || Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.