Cyberonics, Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Cyberonics, Inc
Lot Codes / Batch Numbers
All Model 250 units using Dell x5 handheld computers.
Products Sold
All Model 250 units using Dell x5 handheld computers.
Cyberonics, Inc is recalling Cyberonics, VNS Therapy System Model 250 Handheld programming system using Dell x5 handheld and prep due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
DE, LA
Page updated: Jan 10, 2026