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
Autonomic Nerve Stimulator - Product Code LYJ
원인
Screen freezes-- the dell x5 handheld pc screen will freeze caused due to incompatibility between the microsoft 2002 os and the model dell x5 handheld computer. once frozen, the handheld device becomes non-responsive to user input.
조치
Cyberonics sent an initial notification (Important Safety Alert) to physicians via Certified Mail on 10/01/07. Letter notified physicians that the Dell X5 handheld computer screen will freeze following an interrogation. Once frozen the handheld device becomes non-responsive to user inputs. The firm informed the user that in the event that the computer becomes non-responsive, the user has two options, 1) Reinitialized the flash memory and, 2) Perform a software reset of the handheld computer. A second notification addressing the approval and addition of labeling was sent to physicians on 11/15/07. Physicians were asked to respond to both letters via an enclosed response card, acknowledging receipt of the notification. Additional information will be posted at www.VNStherapy.com.
Worldwide Distribution- USA and the countries of; Austria, Belgium, Denmark, France, Germany, Ile de la Reunion, Ireland, Israel, Italy, Japan, Marocco, Mexico, Netherlands, Ireland, Norway, Poland, Portugal, S. Korea, Slovenia, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.
제품 설명
Cyberonics, VNS Therapy System Model 250 Handheld programming system using Dell x5 handheld and preprogrammed with software v7.1 and higher; manufactured by Cyberonics, Inc., Houston, TX.