Class 2 Device Recall Presice Cryosurgiclal system

• Date Initiated by Firm: December 20, 2010
• Date Posted: February 03, 2011
• Recall Status: Terminated on March 27, 2012
• Recall Number: Z-1031-2011
• Recall Event ID: 57571
• 510(K)Number: K060390
• Product Classification: Unit, cryosurgical, accessories - Product Code GEH
• Product: Presice Cryosurgical System, model FPRCH2047, and the following system is not approved in the US: CryoHit-P Cryoblation System, model FPRCH2058. 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.; Presice is intended for cryogenic destruction of tissue during surgical procedures. Presice 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. Presice 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, ablation of breast fibroadenoma); * 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 Presice system may be used with an ultrasound device to provide real-time visualization of the cryosurgical procedure.
• Code Information: FRCH2047 PI0004 PI0008 PI0022 PI0016 PI0035 PI0013 PI0030 PI0037 PI0027 PI0024 PI0041 PI0042 PI0029 PI0047 PI0048 PI0015 PI0018 PI0049 PI0039 PI0051 PI0052 PI0059 PI0054 PI0055 PI0020 PI0053 PI0063 PI0044 PI0057 PI0068 PI0069 PI0070 PI0025 PI0017 PI0031 PI0019 PI0064 PI0036 PI0032 PI0081 PI0061 PI0043 PI0073 PI0082 PI0014 PI0062 PI0075 PI0071 PI0012 PI0050 PI0040 PI0045 PI0060 PI0072 PI0046 PI0033 PI0076 PI0034 PI0066 PI0021 PI0067 PI0080 FPRCH2058 PI0079 PI0074 PI0078 PI0077
• 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: 63
• 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.