FDAFDA · Food and drugs·Recall number Z-0659-2016
VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Published January 27, 2016 · Recall initiated: December 18, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cyberonics, Inc
- Distributor
- Worldwide Distribution -- United States, Austria, Belgium, Croatia, Czech Republic, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Cyprus, Israel, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, and United Arab Emirates.
- Lot
- All VNS Therapy AspireSR (Model 106) Generators; Device Identifier - (01)05425025750061
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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