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
System, X-Ray, Tomography, Computed - Product Code JAK
원인
Out of specification welding could cause the ceiling mount accessory to detach from its mounting. the firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor.
조치
On 12/3/04, "Urgent: Medical Device Recall" Letters (dated 12/3/04), were mailed via return receipt.
Medical facilities, 1 distributor & 1 physician nationwide. There were also foreign accounts in Canada, United Kingdom, France, The Netherlands and Korea.
제품 설명
Brand Name of Device: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886L. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25''), M (21.50''), and L (34.50''), i.e. 9886L.