Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to ge
FDA device recall Z-0479-2014 · posted 2013-12-11 · Terminated
Recall details
- Recalling firm
- Aesculap, Inc.
- 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.
- Action taken
- Aesculap sent an Important Recall Notification letter dated September 23, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return affected product and receive replacement product or credit. An Inventory Sheet is attached and must be completed. For questions call 610-984-9265 or 610-984-9414.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 85
- Distribution
- Worldwide Distribution - USA Nationwide and countries of: Austria, Germany, Japan, and Taiwan.
- Date initiated
- 2013-09-10
- Date posted
- 2013-12-11
- Date terminated
- 2014-10-20
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AESCULAP BIOPOLAR COAGULATOR (K952524) | Aesculap, Inc. | 1995-06-29 |