Recall Z-0342-2007 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Cyberonics, Inc
Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX.
| Date | Jan 25, 2007 (initiated Oct 17, 2006) |
| Status | Terminated |
| Reason | During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician |
| Root cause | Other |
| Action | Firm sent safety alert to physicians on 11/14/06. Safety Alert informs physicians of the problem and provides instructions on how to avoid an event and correct an event should it occur. |
| Quantity | 7,404 Handheld PCs pre-programmed with software. |
| Distribution | Worldwide Distribution ---- USA and countries of Argentina, Australia, Austria, Belgium, Canada, Cyprus, Czech Rep, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, S. Korea, Sloven |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.