Recall Z-1951-2012— Encision, Inc.

Name: FDA recall Z-1951-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-15

Class II · Terminated

Class II FDA medical device recall by Encision, Inc., initiated 2012-06-15, terminated 2012-08-07. It names one FDA 510(k) clearance: K091074. Product: AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators.. Reason: Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer complaints reporting unanticipated alarms from the AEM monitor while using the device. This issue could result delays or complications during surgical procedures..

Recalling firm: Encision, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-06-15
Terminated: 2012-08-07
Firm location: Boulder, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K091074 — AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIESEncision, Inc.·cleared 2009-08-17

K-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

AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators.

Reason for recall

Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer complaints reporting unanticipated alarms from the AEM monitor while using the device. This issue could result delays or complications during surgical procedures.

Data sourced from openFDA. This site is unofficial and independent of the FDA.