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
Instrument, vitreous aspiration and cutting, ac-powered - Product Code HQE
원인
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
조치
A customer notification letter was sent out on 8/11/2016 to the hospital/surgical center level. Customers were asked to fill out and return a recall acknowledgment form and send back any affected devices.