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
Image-intensified x-ray, fluoroscopic system - Product Code JAA
원인
Ge healthcare precision rxi tilt joystick became stuck in the trendelenburg direction causing the patient to slide off the table. also recall conducted to investigate the possibility of accidentally activation of the remote console joystick where a fatal accident occurred on a non-ge remote r&f; system. .
조치
Two letters "GE Product Safety Notification" dated 12/18/07 and 3/7/08, addressed to Hospital Administrators, Manager of Radiology and Radiologists, were sent to each consignee. Each letter addressed a separate safety issue. Letters described the affected product, safety instructions, corrective action and contact information.
The joystick can become stuck causing unintentional motion of the tube.
Field Modification Instructions (FMI 10802/10803) have been issued to the field to install additional warning labels on the patient table, install a protector for the console joystick and inspect and correct the clearance between the console joystick and its mounting location.
If your facility has a Precision RXi or Precision e system manufactured before March 2007, a GE Healthcare Field Engineer will schedule a field visit to install the added joystick protection. This upgrade will be performed at no charge.
If you have any questions/concerns regarding this issue, please contact your local GE Healthcare sales or service representative.
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제품 설명
GE Healthcare Precision RXi version e Remote X-Ray Imaging R&F; System. It is a remote analog R&F; system consisting of a tilting table with integrated spot film device, and 50KW or 65 kW pulsing generator. The system is configured with a 23 cm image intensifier and a 512x512 Image Chain.