Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 an
FDA device recall Z-0342-2007 · posted 2007-01-25 · Terminated
Recall details
- Recalling firm
- Cyberonics, Inc
- 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
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LYJ
- Quantity affected
- 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, Isr
- Date initiated
- 2006-10-17
- Date posted
- 2007-01-25
- Date terminated
- 2009-10-02
- Location
- Houston, TX
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