Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.
FDA device recall Z-0887-2013 · posted 2013-02-26 · Terminated
Recall details
- Recalling firm
- Aesculap, Inc.
- Reason for recall
- The bipolar energy did not stop after release of the foot pedal.
- Action taken
- Aesculap AG sent an Important Recall Notification letter dated January 21, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory and return for a replacement product or credit. The letter included an inventory sheet to be completed by the customer and returned to the recalling firm. For question call 610-984-9265 or 610-984-9291.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 59
- Distribution
- USA Nationwide Distribution including the states of: AR, CA, FL, IN, IA, KS, MD, MN, MO, OR, TN, TX, VA and WA.
- Date initiated
- 2013-01-18
- Date posted
- 2013-02-26
- Date terminated
- 2014-01-08
- Location
- Center Valley, PA
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