Recall Z-0479-2014— Aesculap, Inc.
Class II · Terminated
Class II FDA medical device recall by Aesculap, Inc., initiated 2013-09-10, terminated 2014-10-20. It names one FDA 510(k) clearance: K952524. Product: 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..
- Recalling firm
- Aesculap, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-10
- Terminated
- 2014-10-20
- Firm location
- Center Valley, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.
Data sourced from openFDA. This site is unofficial and independent of the FDA.