FDA Medical Device Recalls (openFDA)
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 number
- Z-0568-2008
- Recalling firm
- Cyberonics, Inc
- 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.
- Status
- Terminated
- Initiated
- 2007-10-25
- Posted
- 2008-01-29
- Terminated
- 2009-10-05
- Reason
- 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.
- Root cause
- Software design
- Action
- 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.
- 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.
- Lot, serial or model codes
- All Model 250 units using Dell x5 handheld computers.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LYJ
- Firm FEI
- 1000117004
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28