[Recalled] 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 surger
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| 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. |
|---|---|
| Brand / manufacturer | Aesculap, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0479-2014 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 10 September 2013 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.