FDAFDA · Food and drugs·Recall number Z-0479-2014
Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.
Published December 18, 2013 · Recall initiated: September 10, 2013
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
Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aesculap, Inc.
- Distributor
- Worldwide Distribution - USA Nationwide and countries of: Austria, Germany, Japan, and Taiwan.
- Lot
- all GN161's distributed between 4/28/2009 and 5/22/2013.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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