Device Recall SeedNet Cryosurgiclal system 의 리콜

PRCH2035 MA0674 MA0598 MA0479 MA0698 MA0243 MA0332 MA0695 MA0716 MA0736  PRCH2048 MA0665 MA0664 MA0682 MA0686 MA0688 MA0690 MA0689 MA0687 MA0692 MA0694 MA0693 MA0713 MA0342 MA0719

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including CA, CT, FL, GA, MA, MD, MN, MO, NC, NY, OH, PA, SC, TN, TX, VA, and WA and the countries of CANADA, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, ISRAEL, ITALY, KOREA, NETHERLANDS, SPAIN, SWEDEN, TAIWAN, TURKEY, UNITED KINGDOM, CHINA, and JAPAN.CANADA, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, ISRAEL, ITALY, KOREA, NETHERLANDS, SPAIN, SWEDEN, TAIWAN, TURKEY, UNITED KINGDOM, CHINA, JAPAN.

SeedNet MRI Cryosurgical System, model FPRCH2035, and the following system is not approved in the US: CryoHit MRI Cryoblation System, model FPRCH2048. The system is a software controlled cryoblation system designed to destroy targeted tissue using a minimally invasive percutaneous approach. Freezing and thawing of the tissue is achieved through the use of the Joule-Thompson effect, using a high-pressure gas distributed through closed-end needles placed into the patient;s target organ. || The SeedNet System is intended for cryogenic destruction of tissue during surgical procedures. The modified SeedNet is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. The modified SeedNet has the following specific indications: - Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia BPH); - Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention); - Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin); - Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia); - General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions.); - ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth); - Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions); - Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids). The Modified SeedNet System may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure.