Recall Z-0342-2007
Cyberonics, Inc · initiated October 17, 2006
Product
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.
Codes / lots: For Handheld v6.0: 99-0000-3000; For Handheld v6.1: 10-0006-4300; For Handheld v6.1.7: 10-0007-2700, 10-0007-3600, 10-0007-2609 and 77-0000-7000; For Handheld v7.0: 10-0007-4300; For Handheld v7.1.3: 10-0007-8600.
Reason for recall
During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0342-2007
- Initiated
- October 17, 2006
- Posted by FDA
- January 25, 2007
- Terminated
- October 2, 2009
- Product code
- LYJ – Stimulator, Autonomic Nerve, Implanted For Epilepsy
- 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, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.
- Recalling firm
- Cyberonics, Inc, Houston, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0341-2007 | Cyberonics VNS Therapy System, Model 250-''HAND HELD'' programming software v6.1…During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range… | 10/17/2006Terminated |