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
Interventional fluoroscopic x-ray system - Product Code OWB
원인
Malfunction of the radiation-warning timer and the 3d-specific interval warning. no 5-minute timer dialogs or beeper will occur until the unit is rebooted.
조치
Ziehm Imaging, Inc planned action to bring these defects into compliance:
1. You will contact customers and initiate a software update to correct the defects.
2. You will install the software and perform testing to ensure the software update was effective.
3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance.
For further questions, please call (866) 949-4346.