Recall Z-0568-2008
Cyberonics, Inc · initiated October 25, 2007
Product
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.
Codes / lots: All Model 250 units using Dell x5 handheld computers.
Reason for recall
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.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-0568-2008
- Initiated
- October 25, 2007
- Posted by FDA
- January 29, 2008
- Terminated
- October 5, 2009
- Product code
- LYJ – Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Quantity
- 4,201 (US) 199 (International)
- Distribution
- 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.
- Recalling firm
- Cyberonics, Inc, Houston, TX