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
Camera, surgical and accessories - Product Code KQM
원인
User settings were no longer on the monitor's memory after these systems were powered off and back on.
조치
Barco sent an "Urgent Medical Device Correction Notice" dated May 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
This notice contained "Interim Corrective Action" and information about a "Final Corrective Action". The notice included a reply notice to be sent back to Barco and also requested a sub-recall. For further questions, please call (678) 475-8156.