Z-1951-2012 Class II Terminated
FDA device recall Z-1951-2012 was initiated by Encision, Inc. on June 15, 2012 and is designated Class II. 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 coul… The recall status is terminated (terminated August 7, 2012). Affected quantity: 48 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- July 18, 2012
- Initiation Date
- June 15, 2012
- Termination Date
- August 7, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48 boxes
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.
Distribution Pattern
Worldwide Distribution - USA including CA, TX, GA, NY, NC, OH), and New Zealand.
Code Information
RDB, RJB, RJE, RJH, RLG, RLI, RLJ, RLK, RLO, RLP, RLR, RLQ, SBF, SBJ.