Aesculap GNI161 Bipolar Foot Control Recalled for Energy Failure
Aesculap, Inc. is recalling 85 GNI161 Bipolar Foot Controls because the bipolar energy did not stop after the foot control was released.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional failure that poses a risk of harm to patients during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Aesculap, Inc. is recalling 85 units of the GNI161 Bipolar Foot Control. This device is used in surgery to generate electrical power for bipolar instruments in procedures such as neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.
The recall was initiated after complaints were received reporting that the bipolar energy did not stop after the release of the foot control. This failure could result in unintended electrical energy delivery during surgical procedures.
The affected units were distributed worldwide, including the United States, Austria, Germany, Japan, and Taiwan. The recall covers all GNI161 units distributed between April 28, 2009, and May 22, 2013. Healthcare facilities should stop using these devices and contact Aesculap, Inc. for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Aesculap, Inc.
- Affected units
- 85
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all GN161's distributed between 4/28/2009 and 5/22/2013.
Distribution
Distributed nationwide across the United States.
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