Class 2 Device Recall SeedNet Cryosurgiclal system

• Date Initiated by Firm: December 20, 2010
• Date Posted: February 03, 2011
• Recall Status: Terminated on March 27, 2012
• Recall Number: Z-1032-2011
• Recall Event ID: 57571
• 510(K)Number: K021261 K051052
• Product Classification: Unit, cryosurgical, accessories - Product Code GEH
• Product: 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Galil Medical, Inc.; 4364 Round Lake Rd W; Arden Hills MN 55112
• For Additional Information Contact: 484-530-3900 Ext. 1354
• Manufacturer Reason for Recall: This voluntary correction has been initiated due to the discovery of a damaged optocoupler on one of our Presice Systems during periodic preventive maintenance. The optocoupler sends a signal across the locking mechanism in the Presice and Seednet MRI Systems, enabling the software to recognize if the channel on the system manifold is locked or unlocked. If an optocoupler is damaged or malfunction
• FDA Determined Cause: Device Design
• Action: Galil Medical sent an "Urgent Medical Device Correction" letter dated December, 30, 2010, to all affected consignees. The letter described the product, the problem involved, and the action to be taken by the consignee. Consignees were instructed to make sure the locking mechanism on the Precise and Seednet MRI Systems were in the "locked" position when a needle is inserted into the manifold. Gently pull on the black plug to ensure needle is secure in locking mechanism. Apply the enclosed alert sticker on the bottom of the distribution panel and the bottom of the system monitor of the Precise System and on the side of the mobile unit itnerface panel and the top of the system monitor of the Seednet MRI System. Consignees were asked to take a picture of the alert sticker after it has been applied to the appropriate location on their Presice or Seednet MRI System(s) and e-mail to yoni.kadosh@galilmedical.com. Consignees were instructed to complete and return the enclosed form as soon as possible. For questions regarding this recall call Customer Service at (877) 639-2796. problem involved.
• Quantity in Commerce: 22
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GEH and Original Applicant = GALIL MEDICAL LTD.