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
A reported incident of a monitor that fell from the suspension. a fall of a monitor could result in an injury to a patient or operator. recall affects the single and dual lcd monitor suspensions used on precision 500d classical r & f system, precision rxi 23a/32a analog system, precision rxi digital system and precision mpi fluoroscopic imaging systems.
조치
GE Healthcare sent an "Urgent Medical Device Correction" letter dated June 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Perform a visual check before and after each use for the presence of the four (4) mounting screws as shown in the pictures below. Check the secureness of these screws by hand. If these screws are present and secure, you may continue use of the system.
If any of these screws are missing or can easily be turned by hand, follow the precautions below before you continue use with the monitor(s).
1. Position the monitor suspension in the most frequently used position and limit further movement as much as possible.
2. Clearly inform (e.g. through signage and verbal instructions) the users and other auxiliary personnel who may come in contact with the system to not move the monitor suspension once in position.
3. Contact your GE Healthcare representative to inform them of any loose or missing screws.
For questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Worldwide Distribution - US Nationwide Distribution including GU and DC., and to the countries of : Australia, Bulgaria, Canada, Chile, Dominican Republic, Germany, Ireland, Italy, Kuwait, Lebanon, Portugal, Romania, Russia, Saudi Arabia, Slovakia, Spain, Taiwan,Turkey, United Kingdom, Venezuela and Yemen.