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.
FDA Recall Z-1032-2011 · Posted 2011-02-03
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Recalling FirmGalil Medical, Inc.
Recall StatusTerminated
Product CodeGEH
Date Initiated2010-12-20
Date Terminated2012-03-27
Product Quantity22
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
Firm 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 [email protected]. 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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