FDA Enforcement
Class II
Terminated
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.
Recall: Z-0479-2014
·
Reported December 18, 2013
Enforcement
- Recall Number
- Z-0479-2014
- Event ID
- 66533
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Aesculap, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 18, 2013
- Initiation Date
- September 10, 2013
- Classification Date
- December 10, 2013
- Termination Date
- October 20, 2014
- Address
- 3773 Corporate Pkwy, Center Valley, PA, 18034-8217, United States
Description
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.
Reason
Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.
Code Info
all GN161's distributed between 4/28/2009 and 5/22/2013.
Distribution
Worldwide Distribution - USA Nationwide and countries of: Austria, Germany, Japan, and Taiwan.
Quantity
85